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

Model Number	P101828
Medical Device Problem Codes	Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Incontinence (1928); Internal Organ Perforation (1987); Pain (1994); Injury (2348); Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 gian ventral incisional hernia.It was reported that after implant, the patient experienced perforation, severe abdominal and groin pain, bowel obstructions requiring hospitalization, fecal incontinence, and dense adhesions.Post-operative patient treatment included revision surgery, small bowel resections, extensive lysis of adhesions, creation of end ileostomy and mucous fistula, exploratory laparotomy, and mesh removal.

• 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: 8987624
• Report Number: 9617613-2019-00155
• Device Sequence Number: 16866695
• Product Code: FTM
• UDI-Device Identifier: 10884523000139
• UDI-Public: 10884523000139
• 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: 2009
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

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 Expiration Date: 04/11/2010
• Device Model Number: P101828
• Device Catalogue Number: P101828
• Device Lot Number: 075C3-9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/11/2019
• 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: 87