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

Model Number	P152840
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Diarrhea (1811); Purulent Discharge (1812); Fistula (1862); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness/Atrophy (1967); Nausea (1970); Necrosis (1971); Pain (1994); Perforation (2001); Scar Tissue (2060); Scarring (2061); Seroma (2069); Hernia (2240); Discomfort (2330); Injury (2348); Depression (2361); Impaired Healing (2378); Numbness (2415); Fluid Discharge (2686); No Code Available (3191); 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).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 nausea, diarrhea, inflammation, abdominal strength loss, discomfort, infection, necrosis, sinus tract, large scar, seroma/abscess, cellulitis, extensive bowel adhesions to mesh and ongoing, severe pain, abdominal pain, murky drainage, abdominal wound failed to heal with 6-month of wound care, and hernia recurrence.The plaintiff has ongoing medical issues including the need for future medical treatment.
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.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 incisional hernia.It was reported that after implant, the patient experienced nausea, diarrhea, inflammation, abdominal strength loss, discomfort, infection, necrosis, sinus tract, large scar, seroma/abscess, cellulitis, extensive bowel adhesions to mesh and ongoing, severe pain, abdominal pain, murky discharge, impaired healing wound, allergic reaction, fistula, seroma, perforation, depression, numbness, and hernia recurrence.Post-operative patient treatment included medication.
Additional Manufacturer Narrative
Additional information: h6, b2.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.

• 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: justin ellis ; 60 middletown ave.; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 9339890
• Report Number: 9617613-2019-00197
• Device Sequence Number: 2106880
• Product Code: FTM
• UDI-Device Identifier: 10884523000245
• UDI-Public: 10884523000245
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2024

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: 09/30/2013
• Device Model Number: P152840
• Device Catalogue Number: P152840
• Device Lot Number: 10B1801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 09/25/2024; 10/09/2024
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 10/02/2024; 10/16/2024
• 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: Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 102 KG