• 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 PCO6VP
Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506); Material Split, Cut or Torn (4008)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, during an open intraperitoneal onlay mesh umbilical hernia procedure, while placing the mesh it did not open. The surgeon then had to pull out the mesh and they found out that the retaining violet ring was broken at the same time the color change to brown. To resolve the issue, the surgeon made the incision little bigger and used bigger size of mesh in order to complete the case. There was no patient injury.

 
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 Key10301057
MDR Text Key199647043
Report Number9615742-2020-01687
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK120506
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCO6VP
Device Catalogue NumberPCO6VP
Device LOT NumberPSF0448X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/25/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/14/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-