BEUDAMED
    FDA Adverse Event Other Summary report: N

    MILTEX BY KAI

    MDR report key: 53402 · Received November 27, 1996

    Report

    Report Number
    2431021-1996-90001
    Event Type
    Other
    Date Received
    November 27, 1996
    Date of Event
    November 20, 1996
    Report Date
    November 25, 1996
    Manufacturer
    MILTEX INSTRUMENT CO.
    Product Code
    GDX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 11/20/96, AFTER IN OFFICE PROCEDURE SUCCESSFULLY PERFORMED BY THE PHYSICIAN, HE RE-CAPPED THE WORKING END OF THE SCALPEL. THE CAP IS ON THE WORKING END TO PROTECT THE BLADE FOR SHIPPING PURPOSES ONLY. THE PHYSICIAN HOLDING THE SCALPEL IN HIS RIGHT HAND, THEN HOLDING THE CAP RESTING IN HIS LEFT PALM, FIRMLY INSERTED THE BLADE INTO THE CAP, PUNCTURING THE END OF THE CAP AND HIS OWN PALM. PALM HAD A PUNCTURE WOUND, A PRESSURE BANDAGE WAS APPLIED AND PHYSICIAN RECEIVED A TETANUS INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILTEX BY KAI #15 DISPOSABLE SCALPEL GDX MILTEX INSTRUMENT CO. #15 DISPOSABLE SCALPEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other