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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE DS MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PARIETENE DS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PPDS15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abdominal Pain (1685)
Event Date 04/23/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, the patient experienced lower abdominal pain at the surgery site when bending or stretching.

 
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Brand NamePARIETENE DS
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key11590575
MDR Text Key243361039
Report Number9615742-2021-00709
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/30/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/30/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2019
Device MODEL NumberPPDS15
Device Catalogue NumberPPDS15
Device LOT NumberRSA0010X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/04/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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