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

Model Number	P101520
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Adhesion(s) (1695); Cellulitis (1768); Purulent Discharge (1812); Unspecified Infection (1930); Necrosis (1971); Hernia (2240); Unspecified Tissue Injury (4559)
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 ventral hernia.It was reported that after implant, the patient experienced infection, abdominal wall necrosis, wound dehiscence, recurrence, dead skin, mesh separated from abdominal wall, purulent material, cellulitis, and adhesions.Post-operative patient treatment included revision surgery, partial closure with placement of wound vac, rotational flaps of left/right abdominal wall, extended hospitalization, removal of mesh, partial closure of abdominal wound, admission to hospital, debridement of necrosis, and hernia repair with new mesh.

• Brand Name: PERMACOL
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; UK GU11 1EJ
• MDR Report Key: 10976763
• Report Number: 9617613-2020-00092
• Device Sequence Number: 3235146
• 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: 2010
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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 Expiration Date: 04/30/2012
• Device Model Number: P101520
• Device Catalogue Number: P101520
• Device Lot Number: 09B1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P101015 PERMACOL 10X15X1.00 X1 (LOT#09B0501)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention