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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2520
Device Problems Material Erosion (1214); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Corneal Pannus (1447); Adhesion(s) (1695); Atrial Fibrillation (1729); Bacterial Infection (1735); Erosion (1750); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Lupus (1956); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Renal Failure (2041); Sepsis (2067); Septic Shock (2068); Thrombosis (2100); Urinary Tract Infection (2120); Ulcer (2274); Injury (2348); Fungal Infection (2419); 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 midline incisional hernia. It was reported that after implant, the patient experienced severe pain, adhesions, fistula, mesh erosion into colon, colon perforation from mesh and skin necrosis overlying mesh, enterocolic fistula from mesh eroding into colon, end stage renal failure, candida fungemia, epstein-barr viremia, multiple skin bullae. Treatment provided for these conditions include extensive lysis of adhesions and mesh removal.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 laparoscopic therapeutic treatment of a midline incisional hernia. It was reported that after implant, the patient experienced severe pain, adhesions, mesh erosion into colon, colon perforation, enterocolic fistula from mesh eroding into colon, clotting, end stage renal failure, candida fungemia, epstein-barr viremia, infection, thrombocytopenia, intrabdominal free air, sepsis, uti, livedo reticularis, atrial fibrillation, perforated viscus, pannus, ischemic and non-viable tissue, necrosis, systemic lupus erythematosus, hemodynamic instability, brisk bleeding, inflammatory ulcers, septic shock, clot, lesions, invasive fungal wound, and multiple skin bullae. Post-operative patient treatment included revision surgery, 90% mesh removal, lysis of adhesions, take down of fistula, wound debridement, colectomy, evacuation of clot, wound vac, antibiotics, tracheostomy, icu, evacuation of clot, colo-colo anastomosis, punch biopsies of the abdominal wall skin lesions, debridement of necrotizing soft tissue infection abdomen to fascial level, decannulation, and side to side anastomosis of the transverse colon with freeing of the hepatic flexure and splenic flexure.
 
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Brand NameMESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
MDR Report Key8140387
MDR Text Key129568950
Report Number9615742-2018-02691
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2011
Device Model NumberPCO2520
Device Catalogue NumberPCO2520
Device Lot NumberPGJ00417
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/06/2018 Patient Sequence Number: 1
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