BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL SAW

    MDR report key: 10043124 · Received May 8, 2020

    Report

    Report Number
    MW5094441
    Event Type
    Injury
    Date Received
    May 8, 2020
    Date of Event
    July 23, 2018
    Report Date
    May 6, 2020
    Manufacturer
    UNK
    Product Code
    DWI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 6-8 WEEKS POST SURGERY, OPEN PRURITIC LESIONS IN SKIN BEGAN. A MONTH OR TWO LATER NANO-SIZED SQUARE BITS OF LIGHT REFLECTIVE METAL BEGAN SURFACING IN LESIONS AND IN SURROUNDING SKIN OF LEFT FOREARM; CONTINUING TO BE PRESENT IN MINOR SKIN BREAKS (SUCH AS SKINNED KNEE, MINOR BURN ON FOREARM, ABSCESSES APPEARING ON FOREARMS REGULARLY) REQUIRING MEDICAL TREATMENT, BUT NO ONE KNOWS WHAT THIS IS. I CANNOT FIND MEDICAL DIAGNOSTICS OR TREATMENT FOR SYMPTOMS UNTIL I AM TREATING (B)(6). THIS METAL BECOMES TANGLED IN SKIN TISSUE AND ACTUALLY CREATES LARGE LUMPS. IT FEELS LIKE LARGE SPLINTERS AND IS CAUSING HORRIBLE SCARS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504546 SURGICAL SAW SAW, ELECTRICALLY POWERED DWI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other