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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 PCO12
Device Problems Material Erosion (1214); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Foreign Body Reaction (1868); Granuloma (1876); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Staphylococcus Aureus (2058); Scarring (2061); Swelling (2091); Discharge (2225); Hernia (2240); Injury (2348); Fibrosis (3167); 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. After treatment, the patient experienced surgical revision, excision, and lysis of adhesions.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 therapeutic treatment of a spigelian hernia. It was reported that after implant, the patient experienced recurrence, foreign body giant cell reaction, fibrosis, diverticulitis, mesh erosion into viscera, draining wound, pain, redness, swelling, hardness, necrotizing granulomas, scarring, adhesions, infection, abscess. Post-operative patient treatment included surgical revision, excision, removal of infected mesh, colon resection, excision of abdominal wall abscess/skin/fascia/muscle, wound vac, small bowel resection, drainage of intra-abdominal abscess, debridement of infected skin/subcutaneous tissue/fascia/muscle/mesh, exploration and irrigation of draining wound, primary repair of hernia, pulse set irrigation with bacitracin impregnated saline, and lysis of adhesions.
 
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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 Key7702653
MDR Text Key114432213
Report Number9615742-2018-01620
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,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO12
Device Catalogue NumberPCO12
Device Lot NumberPGL00269
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/19/2018 Patient Sequence Number: 1
Treatment
PCO1510OS (LOT# PGJ00216)
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