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

Model Number	P151015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Calcium Deposits/Calcification (1758); Hematoma (1884); Unspecified Infection (1930); Muscle Weakness/Atrophy (1967); Necrosis (1971); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Diaphoresis (2452); Abdominal Distention (2601); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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 an incisional hernia.It was reported that after implant, the patient experienced an open wound, (b)(6), recurrence, prostatic calcifications, atrophy of the right-sided rectus muscle of the anterior abdominal wall, bulging, serous discharge, seroma, pain, wound infection, dehisced surgical wound, hematoma, coughing, night sweats, adhesions, lump, abdominal pain, tenderness, hard/nodular mass, scar tissue, loss of domain, loss of integrity of anterior abdomen, gangrene on the right scrotum, and lipoma.Post-operative patient treatment included revision surgery, incision/drainage of wound, antibiotics, wound vac, excision of dehisced surgical wound, evacuation hematoma, reconstruction rlq, debridement, reconstruction by elevation and transposition of bilateral fasciocutaneous advancement flaps, hernia repair with new mesh, resection horizontally-oriented unstable scar deformity/redundant epidermis/dermis/subcutaneous tissue/fascia within the rlq of anterior abdominal wall measuring, hernia repair with components separation rectus abdominus muscle flaps based upon the inferior epigastric and superior epigastric neurovascular bundles, tissue rearrangement, hernia sac removed, transposition of the rectus abdominus muscle flap for reconstruction of fournier¿s gangrene on the right scrotum, and medication.

• 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: 12449008
• Report Number: 9617613-2021-00030
• Device Sequence Number: 5003274
• Product Code: FTM
• UDI-Device Identifier: 10884523000160
• UDI-Public: 10884523000160
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K120605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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: P151015
• Device Catalogue Number: P151015
• Device Lot Number: 05B37-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/09/2021
• 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: 84