MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES PERMACOL MESH, SURGICAL

Model Number P101520

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Erosion (1750); Calcium Deposits/Calcification (1758); Fistula (1862); Inflammation (1932); Scar Tissue (2060); Ulceration (2116); Hernia (2240); Ulcer (2274); Injury (2348); Impaired Healing (2378); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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 ventral hernia. It was reported that after implant, the patient experienced recurrence, adhesions, fistula, ulcerated hernia sac, inflammation, fibrosis, devascularized hernia sac. , wound opening, wound dehiscence, small bowel evisceration, exposed intestine, gut failure, calcification, scar tissue, ulcers, and mesh erosion into viscera. Post-operative patient treatment included mesh removal, hernia repair with new mesh, lysis of adhesions, evisceration, takedown/repair of gastrocutaneous fistula, repair of enterotomy of the colonic conduit, primary repair of enterotomy of the colon, excised skin/subcutaneous tissue, right/left myofascial advancement flap, closure of fascia, wound vac, primary skin closure, full-thickness biopsy of the deep abdominal wall ulcers, closure of abdomen in 2 layers, and cholecystectomy.

• Brand Name: PERMACOL
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10379880
• MDR Text Key: 203737181
• Report Number: 9617613-2020-00068
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: P101520
• Device Catalogue Number: P101520
• 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: 07/22/2020
• 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: 08/07/2020 Patient Sequence Number: 1