BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPINCE

    MDR report key: 1000354 · Received January 18, 2008

    Report

    Report Number
    MW5005571
    Event Type
    Malfunction
    Date Received
    January 18, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 18, 2008
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A RENAL BIOPSY, WE HAD A BIOPINCE FULL CORE BIOPSY INSTRUMENT THAT WAS UNABLE TO BE COCKED AND USED. WE OPENED ANOTHER PACKAGE AND USED A DIFFERENT BIOPSY GUN. THE LOT NUMBER IS 73381KD5. THE MANUFACTURER IS MEDICAL DEVICE TECHNOLOGIES INC. DATE OF USE: ONE DAY IN 2008. DIAGNOSIS REASON FOR USE: ELEVATED CREATININE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPINCE BIOPSY GUN 18GAX15CM KNW MEDICAL DEVICE TECHNOLOGIES INC. MCXS1815BP 73881KD5

    Patients

    Seq Age Sex Outcome Treatment
    1 YR