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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 UNKNOWN PARIETEX
Device Problems Loss of or Failure to Bond (1068); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Necrosis (1971); Perforation (2001); Pneumothorax (2012); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Respiratory Failure (2484); Abdominal Distention (2601); No Code Available (3191)
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 laparoscopic therapeutic treatment of a recurrent incisional hernia. It was reported that after implant, the patient experienced recurrence, large amount of adhesions of bowel to intra-abdominal wall, previous mesh partially incorporated, abundant serosanguineous drainage, respiratory failure, abdominal wound infection, fistula, and distal jejunal perforation with intra-abdominal soilage of intestinal contents. Post-operative patient treatment included recurrent incisional hernia repair with new mesh, mesh removed from grossly infected field and biliary contents from the peritoneal cavity suctioned free as well as debridement of wound, tracheostomy, removal of remnant mesh, and wound vac.

 
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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 Key8508978
MDR Text Key141757470
Report Number9615742-2019-01252
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 10/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PARIETEX
Device Catalogue NumberUNKNOWN PARIETEX
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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: 04/12/2019 Patient Sequence Number: 1
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