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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 PCO8VP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Diarrhea (1811); Purulent Discharge (1812); Fistula (1862); Foreign Body Reaction (1868); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Vomiting (2144); Chills (2191); Hernia (2240); Impaired Healing (2378); Fluid Discharge (2686); Fibrosis (3167); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: (lot:srg1539); abstack20s sht 5mm sgl use abs dev 20 (lot# n6l0433mx). 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 abscess, infection, infected meshes, draining sinus, necrosis, wound healing issues, fistula tract, chronic granulation tissue, fibrosis, scar tissue, adhesions, inflammation, swelling, recurrence, diarrhea, chills, vomiting, loss of appetite, pain, and suffering. Post-operative patient treatment included revision surgery and lysis of adhesions.

 
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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 Key11386390
MDR Text Key233794863
Report Number9615742-2021-00418
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142908
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 03/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCO8VP
Device Catalogue NumberPCO8VP
Device LOT NumberPRK0369X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/28/2017
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: 02/26/2021 Patient Sequence Number: 1
Treatment
TEM1509G PARIETEX PROGRIP TEM/PLA 15X9CM
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