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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TECR1510
Device Problem 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 medical products: tecr1510 parietex rigid py 15x10 cm x1(lot# soa1031x). 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 and right inguinal hernia. It was reported that after the implant, the patient experienced adhesions, and hernia recurrence. Post-operative patient treatment included additional surgery, and revision surgery.

 
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Brand NamePARIETEX
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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12026222
MDR Text Key259683991
Report Number9615742-2021-01503
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 06/18/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device MODEL NumberTECR1510
Device Catalogue NumberTECR1510
Device LOT NumberSOA1031X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/09/2014
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: 06/18/2021 Patient Sequence Number: 1
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