BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOFORM DERMAL TEMPLATE

    MDR report key: 8371833 · Received February 26, 2019

    Report

    Report Number
    MW5084390
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    May 1, 2018
    Report Date
    February 23, 2019
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    KGN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE USED ENDOFORM DERMAL TEMPLATES ON MY CHRONIC LEG WOUNDS SINCE 2016. I WAS IN A CAR ACCIDENT MANY YEARS AGO AND AM LEFT WITH OPEN WOUNDS ON MY LOWER LEGS THAT MUST REMAIN STERILE. IN (B)(6) 2018 I DEVELOPED A PROGRESSIVE DETERIORATION IN AND AROUND THE WOUNDS WHILE STILL USING THIS PRODUCT. AN INFECTION BEGAN TO SPREAD OUTWARD, TURNING YELLOW AND BLACK WITH THICK COLORED SEEPAGE. I WAS PLACED ON ORAL ANTIBIOTICS FOR A MONTH AND NOW I AM ON TOPICAL ANTIBIOTICS. THE WOUNDS THEMSELVES HAVE TRIPLED IN SIZE AND DOCTORS HAVE BEEN UNABLE TO CONTAIN THE SPREADING. I HAVE NOW RECEIVED A RECALL FOR THE SAME PRODUCTS I HAVE BEEN PLACING ON MY CHRONIC WOUNDS. AROA BIOSURGERY LTD. HAS ISSUED A STATEMENT SAYING THERE IS A QUALITY CONTROL PROBLEM WITH POTENTIAL POUCH SEAL INTEGRITY RENDERING THE PRODUCT NON-STERILE, DATING BACK TO MARCH 2018. I THEREFORE HAVE BEEN PUTTING NON-STERILE BANDAGES ON MY OPEN CHRONIC WOUNDS FOR MONTHS. FREQUENCY? DAILY. HOW WAS IT TAKEN OR USED? TOPICAL. WHY WAS THE PERSON USING THE PRODUCT? (SUCH AS WHAT CONDITION WAS IT SUPPOSED TO TREAT) CHRONIC LEG WOUNDS. THERAPY DURATION? 3 YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165475 ENDOFORM DERMAL TEMPLATE DRESSING, WOUND, COLLAGEN KGN AROA BIOSURGERY LTD. EDT-7H06
    165476 ENDOFORM DERMAL TEMPLATE DRESSING, WOUND, COLLAGEN KGN ARORA BIOSURGERY LTD. EDT-7L02

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| S