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

Model Number	P101520
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• MDR Report Key: 10379880
• Report Number: 9617613-2020-00068
• Device Sequence Number: 3529240
• Product Code: FTM
• UDI-Device Identifier: 10884523000122
• UDI-Public: 10884523000122
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P101520
• Device Catalogue Number: P101520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 55