• 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 TET1515
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Fistula (1862); Foreign Body Reaction (1868); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Ulcer (2274); Deformity/ Disfigurement (2360); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 ventral hernia. It was reported that after the implant, the patient experienced abdominal wound seroma, fluid collection, non-healing wound, exposed mesh, mesh not incorporated, mesh free floating, recurrence, abscess, suture granuloma, inflammation, necrosis, infection, adhesions, and infected mesh. Post-operative patient treatment included wound vac placed, incision/ drainage of abdominal wound seroma, aspiration of fluid collection, removal of mesh, resection of non-healing wound, incision/ drainage of abscess with suture granuloma, debridement of inflamed necrotic tissue, hernia repair with new mesh, and sutures repair of hernia using component separation technique.
 
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
justin ellis
5920 longbow drive
8200 coral sea st ne
mounds view,mn, CO 55112
7635265677
MDR Report Key12025388
MDR Text Key257498085
Report Number9615742-2021-01471
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521180291
UDI-Public10884521180291
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,Followup,Followup
Report Date 10/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model NumberTET1515
Device Catalogue NumberTET1515
Device Lot NumberSQE0522X
Was Device Available for Evaluation? No
Date Manufacturer Received10/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/28/2016
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: 06/18/2021 Patient Sequence Number: 1
-
-