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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 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 Corneal Pannus (1447); Adhesion(s) (1695); Purulent Discharge (1812); Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Scar Tissue (2060); Hernia (2240); Impaired Healing (2378); Fluid Discharge (2686); 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 an incisional hernia. It was reported that after implant, the patient experienced infected mesh, infection, scarring, hernia recurrence, hematoma, wound with persistent drainage, open wound, adhesions, necrotic tissue, granulation tissue, foreign body infection, unincorporated mesh, free floating mesh, purulent material, pannus, open tunnel tracts, sinus tract, pain, diastasis, and oozing. Post-operative patient treatment included revision surgery, wound exploration, excision of mesh, cholecystectomy, debridement of wound, incision and drainage of wound, scar revision, primary repair of hernia, evacuation of hematoma, wound packed with antibiotic containing gauze, granulation tissue debrided, necrotic tissue removed, piece of lower abdominal skin removed, scar revision, pain medication, wounds irrigated with antibiotic solution, and cauterized/coagulation of oozing.

 
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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 Key11715833
MDR Text Key246987234
Report Number9615742-2021-00877
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
Report Date 04/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2012
Device MODEL NumberTET1515
Device Catalogue NumberTET1515
Device LOT NumberSHC00195
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2021
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: 04/23/2021 Patient Sequence Number: 1
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