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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TET1309
Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Anemia (1706); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Sepsis (2067); Discharge (2225); Viral Infection (2248); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Blood Loss (2597); No Code Available (3191)
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 hernia. It was reported that after implant, the patient experienced mesh migration, mesh contracture, lack of incorporation, infected mesh and adhesions. Post-operative patient treatment included revision surgery.

 
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 left inguinal hernia. It was reported that after implant, the patient experienced mesh migration, mesh contracture, lack of incorporation, infected mesh, abscess, purulent fluid, severe inflammatory reaction, severe induration, bleeding, and adhesions. Post-operative patient treatment included revision surgery, mesh explantation, order for one unit of blood, wound vac.

 
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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 Key9321197
MDR Text Key166335699
Report Number9615742-2019-03739
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTET1309
Device Catalogue NumberTET1309
Device LOT NumberSQG0898X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/31/2016
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: 11/14/2019 Patient Sequence Number: 1
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