BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2110898-2016-00098

    MDR report key: 5991975 · Received September 30, 2016

    Report

    Report Number
    2110898-2016-00098
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 1, 2016
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO: INFORMATION NOT PROVIDED. 3M IS INVESTIGATING THIS MATTER AND IS AWAITING THE RETURN OF THE CHARGE STAND. 3M HAS ONLY RECEIVED ONE COMPLAINT OF THIS TYPE. THIS PRODUCT HAS BEEN ON THE MARKET FOR ALMOST TWO YEARS. ADDITIONAL INFORMATION WILL BE PROVIDED AT A SUBSEQUENT DATE. END OF REPORT.

    Description of Event or Problem · 1

    THE HOSPITAL RISK MANAGEMENT DIRECTOR REPORTED ON SEPTEMBER 16, 2016 THAT A FEMALE EMPLOYEE, AGE UNSPECIFIED, REMOVED A 3M CLIPPER (MODEL 9681) WITH ATTACHED BLADE FROM THE CHARGER BASE ON (B)(6) 2016 AFTER IT HAD BEEN CHARGING ALL NIGHT. THE EMPLOYEE ALLEGED THAT THE CLIPPER "IGNITED" KIND OF EXPLODED". EARLY IN THE AFTERNOON, A NURSE REMOVED THE CLIPPER AND ATTACHED BLADE FROM THE CHARGER STAND. THE NURSE ALLEGED THAT A SPARK WAS SEEN AS SOON AS THE CLIPPER WAS REMOVED FROM THE CHARGER STAND. THE CLIPPER ALLEGEDLY STARTED ON FIRE WITH FLAMES WERE VISIBLE. THE EMPLOYEE ALLEGED A SECOND-DEGREE BURN TO HER RIGHT THUMB. SHE WAS SEEN IN THE HOSPITAL EMERGENCY ROOM PER PROTOCOL AND WAS GIVEN AN UNSPECIFIED CREAM AND SENT HOME. ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 22, 2016 INDICATED THE CLIPPER HAD BEEN CLEANED WITH A DISINFECTANT WIPE AND PLACED IN THE CHARGER STAND OVERNIGHT BEFORE USE.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CHARGER STAND 9682