• 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 UNKNOWN PARIETEX PRODUCT 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 UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Purulent Discharge (1812); Edema (1820); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); Injury (2348); Hematuria (2558); Ascites (2596); Bowel Perforation (2668); 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 a bilateral inguinal hernia. It was reported that after implant, the patient experienced abdominal pain, pain in the left groin, nausea, vomiting, hematuria, sigmoid colon perforation, inguinal hernia recurrence that was incarcerated, ascites, aponeurosis, abscess and purulent material. Post-operative patient treatment included left inguinal hernia recurrence repair, removal surgery, ascitic fluid suction, partial excision of aponeurosis, incision/drainage of abscess, abscessogram under fluoroscopic guidance and aspiration of purulent material.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN PARIETEX PRODUCT
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 Key8987481
MDR Text Key157457338
Report Number9615742-2019-03021
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
Report Date 09/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX PRODUCT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2019
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: 09/11/2019 Patient Sequence Number: 1
-
-