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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 PCO4VP
Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Pain (1994); Scarring (2061); Hernia (2240); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 hernia. It was reported that after the implant, the patient experienced recurrence, failure of mesh, meshoma, contraction of mesh, pain, and scarring. Post-operative patient treatment included removal of 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
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key10656766
MDR Text Key210647430
Report Number9615742-2020-02308
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120506
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 10/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2016
Device MODEL NumberPCO4VP
Device Catalogue NumberPCO4VP
Device LOT NumberPNC0214
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2020
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: 10/09/2020 Patient Sequence Number: 1
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