MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PERMACOL MESH, SURGICAL

Model Number P151520

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Purulent Discharge (1812); Inflammation (1932); Nausea (1970); Renal Failure (2041); Sepsis (2067); Vomiting (2144); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Respiratory Failure (2484); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

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. H6:patient code-c64343(evisceration; dehydration; leukocytosis). 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 recurrent ventral incisional hernia. It was reported that after implant, the patient experienced recurrence, wound dehiscence with evisceration, grossly distended abdomen, drainage from skin incision, bowel nearly protruding through skin incision, light fibrinous inflammatory adhesions, extensive gaseous distended ileus, sepsis, respiratory failure, purulent material in subcutaneous space, fibrinous adhesions, abdominal bloating, nausea, vomiting, non-healing wound on abdomen, bowel obstruction, dehydration, acute renal failure, leukocytosis, and multiple hospitalizations. Post-operative patient treatment included revision surgeries, lysis of adhesions, exploratory laparotomy, and mesh removal.

• Brand Name: PERMACOL
• Type of Device: MESH, SURGICAL
• 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 Key: 9472484
• MDR Text Key: 170869618
• Report Number: 9615742-2019-03864
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2013
• Device Model Number: P151520
• Device Catalogue Number: P151520
• Device Lot Number: 10B1408
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2019
• 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: 12/16/2019 Patient Sequence Number: 1

Treatment

P151520 (LOT#: 10B1201)