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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 PCO8VP
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Failure of Implant (1924); Hernia (2240); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative

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 an incisional hernia. It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, adhesions to the failed mesh, and unincorporated mesh. Post-operative patient treatment included mesh revision surgery, mesh removal surgery and implant of new mesh.

 
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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 Key12027033
MDR Text Key257117613
Report Number9615742-2021-01522
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142908
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 MODEL NumberPCO8VP
Device Catalogue NumberPCO8VP
Device LOT NumberPRK1109X
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
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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