BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDYSEAL

    MDR report key: 412181 · Received July 9, 2002

    Report

    Report Number
    1420141-2002-00048
    Event Type
    Injury
    Date Received
    July 9, 2002
    Date of Event
    July 1, 2002
    Report Date
    July 9, 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

    THIS INCIDENT WAS REPORTED TO THE BAXTER U.S. PRODUCT SURVEILLANCE ON 8/19/02. IT WAS FIRST REPORTED TO BAXTER EUROPE ON 7/4/02. THE REPORT STATED THAT THE CUSTOMER HAD EXPERIENCED ONGOING PROBLEMS WITH SEAL QUALITY WHEN USING PALL BLOOD BAGS. THE CUSTOMER BELIEVED THAT IF PRESSURE WAS APPLIED TO THE SEALING HEAD DURING THE SEALING PROCESS THE QUALITY OF THE SEAL WOULD IMPROVE. TWO OPERATORS WERE USING THEIR FOREFINGERS TO APPLY PRESSURE. THEIR FINGERS SLIPPED FROM THE SEALING HEAD AND CAME INTO CLOSE PROXIMITY TO THE ELECTRODE. IN BOTH INSTANCES THERE WERE WOUNDS AND THE CENTER MGR STATED THERE WAS A SMELL OF BURNING FLESH. THEY WERE EXAMINED BY A NURSE WHO REPORTED THAT THE WOUNDS WERE DEEP AND CONSISTENT WITH ELECTRICAL BURNS. THE OPERATORS WERE GIVEN FIRST AID. NO FOLLOW-UP INFO WAS PROVIDED REGARDING THESE OPERATORS. THIS REPORT IS FOR ONE INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other