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

Model Number	P151828
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Purulent Discharge (1812); Erythema (1840); Fistula (1862); Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Seroma (2069); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); 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 umbilical hernia.It was reported that after the implant, the patient experienced seroma, failure of mesh, infection, and fistulizing mesh.Post-operative patient treatment included revision surgery, wound vac, and numerous irrigations and debridements of wound/infection.
Additional Manufacturer Narrative
Additional info: a3a, b5, b7, d8, e1 (street 1, city, region, postal code), h6 (patient codes, device codes, ime e2402: sinus tract, loss of domain), <(>&<)> additional codes medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an umbilical hernia.It was reported that after the implant, the patient experienced seroma, failure of mesh, infection, fistulizing mesh, fat necrosis, draining sinus tract, granuloma, adhesions, open wound, bowel obstruction, purulent drainage, inflammation, pain, suffering, erythema, loss of domain.Post-operative patient treatment included revision surgery, wound vac, numerous irrigations and debridement of wound/infection, incision drainage of seroma, mesh removal, exploratory laparotomy, hernia repair mesh, lysis of adhesions, ileocecectomy, abdominal washout, ileal colectomy, small bowel resection.

• 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
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view,mn, CT 55112-4391 ; 8006464633
• MDR Report Key: 9963554
• Report Number: 9617613-2020-00049
• Device Sequence Number: 2785012
• Product Code: FTM
• UDI-Device Identifier: 10884523000191
• UDI-Public: 10884523000191
• 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: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: 07/31/2013
• Device Model Number: P151828
• Device Catalogue Number: P151828
• Device Lot Number: 09B2907
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/11/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PCO3020(LOT#: PHI00564); PCO3020(LOT#: PHI00564)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female