• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO20X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Erythema (1840); Unspecified Infection (1930); Pain (1994); Renal Failure (2041); Scarring (2061); Sepsis (2067); Seroma (2069); Shock (2072); Hernia (2240); Injury (2348); Impaired Healing (2378); Coma (2417); Obstruction/Occlusion (2422); Respiratory Failure (2484); Abdominal Distention (2601); 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 laparoscopic therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced pain, scarring, redness, bulging irritable bowel syndrome, adhesions, infection, bacteremia, ileus, erythema, abscess, seroma, non-healing wound, intestinal/ bowel obstruction and blockage, abdominal sepsis, shock, acute renal/ kidney failure, respiratory failure, coma, and recurrence. Post-operative patient treatment included additional surgery and hospitalization.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10740915
MDR Text Key213215761
Report Number9615742-2020-02399
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 10/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2014
Device MODEL NumberPCO20X
Device Catalogue NumberPCO20X
Device LOT NumberPMI00114
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/19/2013
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: 10/27/2020 Patient Sequence Number: 1
-
-