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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 Material Erosion (1214); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Erythema (1840); Fistula (1862); Inflammation (1932); Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Hernia (2240); Injury (2348); Impaired Healing (2378); Abdominal Distention (2601); Weight Changes (2607); 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 an incisional hernia. It was reported that after implant, the patient experienced recurrence, severe pain, extensive adhesions, mesh eroded into small bowel, large hole in small bowel, small bowel removal, fistula, nausea, diarrhea, inflammation, bloating, loss of appetite, extreme weight loss, wound healing issues, ileus, erythema of the abdominal wall, and fluctuant area of the midline abdomen. Post-operative patient treatment included revision surgery, extensive lysis of adhesions, small bowel resection, explantation 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 Key8954011
MDR Text Key156300822
Report Number9615742-2019-02950
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,Followup
Report Date 11/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2019
Device MODEL NumberPCO4VP
Device Catalogue NumberPCO4VP
Device LOT NumberPCB0721
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2019
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: 09/02/2019 Patient Sequence Number: 1
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