• 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 TET3030
Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
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 a parastomal hernia. It was reported that after implant, the patient experienced mesh contraction, and the mesh was somewhat tight at stoma site which was likely leading to a partial bowel obstruction. Post-operative patient treatment included revision surgery, and bowel resection.
 
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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key11843842
MDR Text Key251369267
Report Number9615742-2021-01242
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521180185
UDI-Public10884521180185
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2017
Device Model NumberTET3030
Device Catalogue NumberTET3030
Device Lot NumberSMF00215
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/23/2012
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: 05/18/2021 Patient Sequence Number: 1
-
-