BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOFORM DERMAL TEMPLATE

    MDR report key: 8420709 · Received March 13, 2019

    Report

    Report Number
    MW5084906
    Event Type
    Injury
    Date Received
    March 13, 2019
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    KGN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BLISTER ON TOE. VISIT TO DOCTOR IN (B)(6) (B)(6) 2018. PRESCRIBED ENDOFORM DERMAL TEMPLATE (AROA BIOSURGERY) - RECEIVED (B)(6) 2018, USED AS PRESCRIBED. WOUND WORSENED AND DEVELOPED ODOR - BONE VISIBLE. SAW DOCTOR IN (B)(6) (B)(6) 2018, ORDERED CAT SCAN. REVIEWED WITH DOC THE RESULTS OF CAT SCAN. VISITED FOOT ORTHOPEDIC SURGEON. TEST SHOWED BONE INFECTION. AGREED TO TOE AMPUTATION (B)(6) 2018. SURGERY TO REMOVE INFECTED TOE (B)(6) 2019. (B)(4) MEDICAL PRODUCTS. STRENGTH: 2" X 2'. QUANTITY: 1 SMALL PIECE. FREQUENCY: DAILY. HOW WAS IT TAKEN OR USED? ON SKIN. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2018. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2018. WHY WAS THE PERSON USING THE PRODUCT? BLISTER ON TOE #2, LEFT FOOT. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210314 ENDOFORM DERMAL TEMPLATE DRESSING, WOUND, COLLAGEN KGN AROA BIOSURGERY LTD. EDT 7L01

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R| S