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This report describes post-market surveillance (PMS) activity output as described in the PMS plan for Vestibulum ac diam sit amet quam vehicula elementum. It includes the results of the PMS activities and the conclusions drawn from the data collected.
Surveillance Period:
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Legal Manufacturer Name: Consectetur Adipiscing Ltd.
Address: 1234 Ipsum Street, Dolor City, EU 56789
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Notified Body Name: Notified Body GmbH
Notified body Number: 0123
Single Registration Number: SRN123456789
UDI-DI: UDI123456789
Product or trade name: Vestibulum ac diam sit amet quam vehicula elementum.
Software Version: v2.3.1
General description of the device: Etiam porta sem malesuada magna mollis euismod.
Intended purpose: Ut enim ad minim veniam, quis nostrud exercitation.
Intended users: Ut wisi enim ad minim veniam, quis nostrud.
Intended patient population: Curabitur arcu erat, accumsan id imperdiet et, porttitor at sem.
Medical condition(s): Morbi leo risus, porta ac consectetur ac, vestibulum at eros.
Indications: Maecenas sed diam eget risus varius blandit sit amet non magna.
Contraindications: Nulla vitae elit libero, a pharetra augue.
Warnings: Fusce dapibus, tellus ac cursus commodo, tortor mauris condimentum nibh.
Variants and/or configurations: Aenean eu leo quam. Pellentesque ornare sem lacinia quam venenatis vestibulum.
Accessories: Donec ullamcorper nulla non metus auctor fringilla.
Class: IIb
Classification rule: Donec sed odio dui. Etiam porta sem malesuada magna mollis euismod.
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Date First Introduced to the market: 01 January 2021
State of the Device: Currently available on all major markets.
Differences by Basic UDI-DI: Minor software updates and packaging variations.
Volume of Sales by Region Over Time
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*EAA = European Economic Area, TR = Turkey, XI = Iceland
For the above table, total number of devices refers to:
Sum of shipped devices to all regions during the reporting period.
Patient Exposure by Region Over Time
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*EAA = European Economic Area, TR = Turkey, XI = Iceland
The above references for total number of patients refers to the following:
Estimated based on device usage data and feedback from clinical sites.
The following data concern serious incidents that have occurred from use of the device. The data are reported using the IMDRF Adverse Event Terminology if available. Descriptions of the IMDRF Adverse Event Terms (according to IMDRF/AE WG/N43FINAL:2020 (Edition 4)) by annex are listed below as well. If the IMDRF AET is unknown, it is included with the total incident count.
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*EAA = European Economic Area, TR = Turkey, XI = Iceland
Summary of new serious incidents:
No new serious incidents reported since last reporting period.
No significant trends identified in the reporting period.
The following table contains Field Safety Corrective Actions (FSCAs) that have occurred since the last PSUR.
No FSCAs have been initiated during this reporting period.
The following table contains Corrective and Preventive Actions (CAPAs) that have occurred since the last PSUR.
One CAPA initiated to address minor labeling issue.
Feedback and complaints from users, distributors, and importers and complaints not reported in the vigilance section above are included here. The following table contains the number of complaints and feedback received since the last PSUR. The types of complaints included in this table include those relevant to the safety and performance of the device and are not included in the vigilance section above.
Three minor complaints received regarding device usability.
*EAA = European Economic Area, TR = Turkey, XI = Iceland
CAPAs as a Result of Complaints
CAPA implemented to update user instructions based on feedback.
An in depth scientific literature review is performed during the clinical evaluation procedures. This can be found in the Clinical Evaluation Report. The literature analyzed in the most recent clinical evaluation report includes the following data:
Ten relevant articles were identified and reviewed.
The summary of the literature search results is as follows:
No new risks identified; findings support current safety profile.
As part of the clinical evaluation, the clinicaltrails.gov database was searched for any clinical trials related to the device or the state of the art. A summary of the clinical trials can be found in the Clinical Evaluation Report. The clinical studies that were identified are in the table below:
No ongoing or completed clinical trials identified for this device.
As part of the clinical evaluation, international vigilance databases from FDA MAUDE, FDA Recall, BfArM, and Swissmedic were searched for any incidents related to the device or the state of the art. A summary of the incidents can be found in the Clinical Evaluation Report. The incidents that were identified are in the table below:
No relevant incidents found in public vigilance databases.
As part of the clinical evaluation, an analysis of similar devices including the state of the art was performed. The results of the analysis can be found in the Clinical Evaluation Report. A summary of similar devices are presented in the following table.
Comparable devices reviewed; no significant differences identified.
A summary of the literature related to the state of the art is as follows:
Recent publications confirm the safety and performance of devices in this category.No new safety concerns identified in the literature.
PMCF activities confirm continued safety and performance.
The collected data are from multiple sources and are representative of the device's safety and performance. The data are sufficient to draw conclusions and an impact on the benefit-risk ratio as well as dependent technical documentation has been possible.
No significant limitations noted in the data sources.
The benefit-risk ratio of the device remains favorable.
No additional actions required at this time. Monitoring will continue.
