BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDLYSEAL

    MDR report key: 420425 · Received September 26, 2002

    Report

    Report Number
    1420141-2002-00056
    Event Type
    Injury
    Date Received
    September 26, 2002
    Date of Event
    August 9, 2002
    Report Date
    August 27, 2002
    Manufacturer
    CONROY MEDICAL AB
    Product Code
    KSD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE OPERATOR WAS HAVING DIFFICULTIES SEALING THE TUBING ON PALL BLOOD BAGS. IT WAS BELIEVED BY THE STAFF AT THE CENTER THAT IF PRESSURE WAS APPLIED TO THE SEALER HEAD DURING THE SEALING PROCESS THE QUALITY OF THE SEAL WOULD IMPROVE. THE OPERATOR WAS USING A FOREFINGER TO APPLY PRESSURE. THE OPERATOR'S FOREFINGER SLIPPED FROM THE SEALER HEAD AND CAME INTO CLOSE PROXIMITY OF THE ELECTRODES. THE FINGER WAS BURNED AND THE CENTER MGR STATED THE INCIDENT WAS ACCOMPANIED BY THE SMELL OF BURNING FLESH. THE OPERATOR WAS GIVEN FIRST AID. A NURSE EXAMINED THE WOUND AND REPORTED THAT IT WAS DEEP AND CONSISTENT WITH AN ELECTRICAL BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDLYSEAL SEALER KSD CONROY MEDICAL AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other