BEUDAMED
    FDA Adverse Event Other Summary report: N

    DC MEDICAL (FORMALLY DERMACARE)

    MDR report key: 105813 · Received July 14, 1997

    Report

    Report Number
    1530493-1997-90001
    Event Type
    Other
    Date Received
    July 14, 1997
    Date of Event
    June 13, 1997
    Report Date
    July 13, 1997
    Manufacturer
    D.C. MEDICAL
    Product Code
    MMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING A DC MEDICAL NEEDLE-COUNTER, A FOAM STRIP (PART OF THE NEEDLE COUNTER) LEFT LOOSE AND ALLEGEDLY CAUSED A NEEDLE-STICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DC MEDICAL (FORMALLY DERMACARE) NEEDLE COUNTER (DISPOSAL SYSTEM) MMK D.C. MEDICAL 20-4301 020797

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other SUTURE NEEDLES & SUTURE HOLDER| INFORMATION NOT AVAILABLE, BUT MAY HAVE BEEN