BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL

    MDR report key: 20398470 · Received October 8, 2024

    Report

    Report Number
    9617613-2024-00008
    Event Type
    Injury
    Date Received
    October 8, 2024
    Report Date
    October 18, 2024
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDED ADDITIONAL CODE. 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 · 0

    D10 (PERMACOL PORCINE COLLAGEN, PRODUCT ID - 5120-150, LOT # - 07B12-4), H6 IME E2402: SINUS, INDURATION 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.

    Description of Event or Problem · 0

    DURING REVIEW OF MEDICAL RECORDS RECEIVED FROM THE PATIENT'S ATTORNEY, IT WAS IDENTIFIED THAT AFTER THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA THE PATIENT EXPERIENCED HERNIA RECURRENCE, INFLAMMATION, FIBROUS ADHESIONS, STAPH AUREUS, LUMP, WOUND RED TENDER, LEAKING WOUND, FLUCTUANT SWELLING, FLUCTUANT COLLECTION UNDER THE SKIN, ULCERATION, PUS, INFECTION, INFECTED SINUS WITH BLOOD PUS LEAKING, INDURATION, PAIN, DISTRESS, SCARRING, CELLULITIS, EDEMA, BOIL-LIKE LESION BURST LEAKING THICK YELLOW FLUID FOLLOWED BY BLOODSTAINED SEROUS FLUID, FISTULATION OF ABDOMINAL WALL COLLECTION, RAISED FLUCTUANT LESION ALONG WOUND, DISTENDED ABDOMEN, DISCOMFORT, ABDOMINAL PAIN, BLOOD DRAINING FROM SINUS/FISTULA SITES, BRUISING, CYSTS, ABDOMINAL DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, MULTIPLE ROUNDS OF ANTIBIOTICS, PAIN MEDICATION, ASPIRATION OF BLOOD, WOUND CARE, DRAINAGE OF PUS INFECTION, SURGICAL DRAINAGE OF INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685433 PERMACOL MESH, SURGICAL, POLYMERIC FTL TISSUE SCIENCE LABORATORIES 5230-150 06B07-9

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 COMMENT.