• 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 MESH SOFRADIM - PARIETEX OPTIMIZED COMPOSITE MESH 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 MESH SOFRADIM - PARIETEX OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO4VP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Inflammation (1932); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Constipation (3274)
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 therapeutic treatment of an umbilical hernia. It was reported that after implant, the patient experienced bowel obstruction, inflammation and adhesions. Post-operative patient treatment included revision surgery.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH SOFRADIM - PARIETEX OPTIMIZED COMPOSITE MESH
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 Key8457939
MDR Text Key140079053
Report Number9615742-2019-00748
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,Followup,Followup,Followup
Report Date 10/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device MODEL NumberPCO4VP
Device Catalogue NumberPCO4VP
Device LOT NumberPOD0478
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
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: 03/27/2019 Patient Sequence Number: 1
-
-