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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number LPG1510
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Hernia (2240); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative

Concomitant product: lpg1510 10x15 cm lp progrip flatsheetmsh (lot# prj0090x). If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a left / right inguinal hernia. It was reported that after implant, the patient experienced recurrence, mesh migration, mesh was bunched up medial to the internal ring, and adhesions. Post-operative patient treatment included revision surgery and partial removal of surgical mesh.

 
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Brand NamePROGRIP
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 Key11090310
MDR Text Key224162979
Report Number9615742-2020-02947
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123479
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 12/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2020
Device MODEL NumberLPG1510
Device Catalogue NumberLPG1510
Device LOT NumberPRI0139X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/24/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/29/2020 Patient Sequence Number: 1
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