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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 PCO12X
Device Problems Material Erosion (1214); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Internal Organ Perforation (1987); Sepsis (2067); Hernia (2240); Injury (2348); Abdominal Distention (2601)
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. Product was used for therapeutic treatment of an umbilical hernia. It was reported that after implant, the patient experienced a recurrent ventral hernia, mesh erosion into viscera, and mesh infection. Post operative treatment included recurrent hernia repair, removal of infected mesh, and small bowel resection.

 
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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 Key8967975
MDR Text Key156712930
Report Number9615742-2019-02996
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2018
Device MODEL NumberPCO12X
Device Catalogue NumberPCO12X
Device LOT NumberPOA0358X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/18/2014
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: 09/05/2019 Patient Sequence Number: 1
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