MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PERMACOL; MESH, SURGICAL

Model Number	P151015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Bacterial Infection (1735); Muscle Weakness/Atrophy (1967); Necrosis (1971); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330); Abdominal Distention (2601); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant product: p100510 permacol 5x10x1.00 x1, lot number: 07b09-1.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 laparoscopic therapeutic treatment of an inguinal hernia.It was reported that after the implant, the patient experienced recurrence, bulging, tenderness, hard/nodular tumor mass, scar tissue, loss of domain, loss of integrity of anterior abdomen, gangrene on the right scrotum, (b)(6), abdominal pain, pain, and lipoma.Post-operative patient treatment included revision surgery, 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): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 12481098
• Report Number: 9615742-2021-02219
• Device Sequence Number: 19817475
• 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: 2009
• 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): 09/16/2021

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 Expiration Date: 07/31/2011
• Device Model Number: P151015
• Device Catalogue Number: P151015
• Device Lot Number: 08B1009
• 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: 09/16/2021
• 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