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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 PCO2520X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
Event Type  Death  
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 a ventral hernia. It was reported that after the implant, the patient experienced abscess, fistula, wound drainage, pain, infection, infected mesh, purulent material, necrotic tissue, small bowel obstruction, dermatitis, perifistular skin, abdomen distention, and death. Post-operative patient treatment included revision surgeries, incision/drainage of abscess, abscess cavity packed with betadine soaked gauze, admission to hospital, change of eakin pouch, iv fluids given, wound therapy, and debridement of necrotic tissue. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.

 
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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 Key11616864
MDR Text Key243861950
Report Number9615742-2021-00791
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 04/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device MODEL NumberPCO2520X
Device Catalogue NumberPCO2520X
Device LOT NumberPOB0569X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/06/2014
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: 04/05/2021 Patient Sequence Number: 1
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