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

Model Number	P151520
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Purulent Discharge (1812); Fever (1858); Fistula (1862); Flatus (1865); Foreign Body Reaction (1868); Granuloma (1876); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness/Atrophy (1967); Pain (1994); Scar Tissue (2060); Seroma (2069); Abnormal Vaginal Discharge (2123); Electrolyte Imbalance (2196); Hernia (2240); Ulcer (2274); Discomfort (2330); Obstruction/Occlusion (2422); Ascites (2596); Constipation (3274); Unspecified Gastrointestinal Problem (4491); Sexual Dysfunction (4510); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of incisional hernia.It was reported that after the implant, the patient experienced mesh failure, infection, fistula, adhesions, chronic pain, hematoma, labs abnormal for rbc; hemoglobin; hematocrit; albumin; bun; glucose; phosphorous, fluid collection, seroma, foreign body giant cell reaction, suture granuloma, fibroadipose tissue, ulceration, inflammation, mucosa shows foci of superficial erosion, gas pains, constipation, abdominal pain, discomfort, blood drainage from umbilical incision, fever, diarrhea, purulent discharge, mesh unincorporated floating, ileum colon dilated, colon thinner walled, enteric contents draining from vagina, sexual intercourse uncomfortable, serosal tears, thin apex of vagina, retained stool, erosion of mesh into bowel, scarring, attenuated muscle fascia.Post-operative patient treatment included mesh removal, revision surgery, small bowl resection, wound vac, ct scan, physical therapy, iv fluid, medication, multiple hospitalizations, evacuation of hematoma, iv hydration analgesia, antibiotics, wou nd care, repair of fistula, mesh revision, external oblique component release/advancement flaps, total abdominal colectomy, takedown of splenic flexure, takedown of colostomy, end ileostomy, use of jp drain, exploratory laparotomy, primary repair of hernia, primary repair of vagina, rigid proctoscopy, rigid vaginoscopy, serosal tears oversewn, sutures removed from rectal stump, endoscopy, laparotomy, lysis of adhesions, ileostomy revision.
Additional Manufacturer Narrative
H6 ime e2402: labs abnormal for rbc; hemoglobin; hematocrit; albumin; bun; phosphorous, fibroadipose tissue, colon thinner walled, thin apex of vagina, retained stool 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 incisional hernia.It was reported that after the implant, the patient experienced recurrence, obstructions, bowel issues, mesh failure, infection, fistula, adhesions, chronic pain, hematoma, labs abnormal for rbc; hemoglobin; hematocrit; albumin; bun; glucose; phosphorous, fluid collection, seroma, foreign body giant cell reaction, suture granuloma, fibroadipose tissue, ulceration, inflammation, mucosa shows foci of superficial erosion, gas pains, constipation, abdominal pain, discomfort, blood drainage from umbilical incision, fever, diarrhea, purulent discharge, mesh unincorporated <(>&<)> floating, ileum <(>&<)> colon dilated, colon thinner walled, enteric contents draining from vagina, sexual intercourse uncomfortable, serosal tears, thin apex of vagina, retained stool, erosion of mesh into bowel, scarring, <(>&<)> attenuated muscle fascia.Post-operative patient treatment included mesh removal, revision surgery, small bowl resection, colon resection, wound vac, ct scan, physical therapy, iv fluid, medication, multiple hospitalizations, evacuation of hematoma, iv hydration <(>&<)> analgesia, antibiotics, wound care, repair of fistula, mesh revision, external oblique component release/advancement flaps, total abdominal colectomy, takedown of splenic flexure, takedown of colostomy, end ileostomy, use of jp drain, exploratory laparotomy, primary repair of hernia, primary repair of vagina, rigid proctoscopy, rigid vaginoscopy, serosal tears oversewn, sutures removed from rectal stump, endoscopy, laparotomy, lysis of adhesions, <(>&<)> ileostomy revision.
Additional Manufacturer Narrative
Additional info: a4, b5, b7, h6 (patient 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.

• 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
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; UK GU11 1EJ
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21506465
• Report Number: 9617613-2025-00002
• Device Sequence Number: 7974690
• Product Code: FTM
• UDI-Device Identifier: 10884523000184
• UDI-Public: 10884523000184
• 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: 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): 04/01/2025

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: 01/30/2013
• Device Model Number: P151520
• Device Catalogue Number: P151520
• Device Lot Number: 09B2108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/01/2025
• 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; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Race: White