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

Model Number	P101828
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Emotional Changes (1831); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Scarring (2061); Seroma (2069); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); 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 a ventral hernia.It was reported that after implant, the patient experienced adhesions, recurrence, scarring and pain.Post-operative patient treatment included mesh removal surgery and additional implants.
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, hematoma, obstruction, seroma, chronic abdominal wound, mesh failure, loss of abdominal domain, suffering, adhesions, recurrence, scarring and pain.Post-operative patient treatment included medication, incision and drainage of wound, wound exploration, evacuation of hematoma, debridement, closure over drain, wound vac, laparotomy, lysis of adhesions, external oblique aponeurosis release of component separation and adjacent tissue transfer, mesh removal surgery and hernia repairs with new meshes.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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 a ventral hernia.It was reported that after implant, the patient experienced infection, hematoma, obstruction, seroma, chronic abdominal wound, meshfailure, loss of abdominal domain, suffering, adhesions, recurrence, scarring, pain, abdominal pain, mental pain, suffering, permanent injury, disability, impairment, loss of enjoyment of life, device defective.Post-operative patient treatment included medication, incision and drainage of wound, wound exploration, evacuation of hematoma, debridement, closure over drain, wound vac, laparotomy, lysis of adhesions, external oblique aponeurosis release of component separation and adjacent tissue transfer, mesh removal surgery, hernia repairs with new meshes, medical treatment.

• 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 ; 60 middletown ave; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 8006464633
• MDR Report Key: 9800919
• Report Number: 9617613-2020-00040
• Device Sequence Number: 778429
• Product Code: FTM
• UDI-Device Identifier: 10884523000139
• UDI-Public: (01)10884523000139(17)151231(10)12B0407
• 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: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2025

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: 12/31/2015
• Device Model Number: P101828
• Device Catalogue Number: P101828
• Device Lot Number: 12B0407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/12/2025; 09/03/2025
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 03/18/2025; 09/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Male
• Patient Weight: 98 KG