BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITEHALL

    MDR report key: 8114758 · Received November 29, 2018

    Report

    Report Number
    2222003-2018-00003
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    January 1, 2018
    Report Date
    November 27, 2018
    Manufacturer
    FABRICACION Y MANUFACTURAS DE MEXICO S.A. DE C.V.
    Product Code
    IRQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A WHITEHALL REPRESENTATIVE AT A SHOW WAS APPROACHED BY A FEMALE ATTENDEE TO TELL THE REP ABOUT A PROBLEM SHE HAD WITH A SPLINT PAN. SHE STATED THAT A SPLINT PAN HAD "BURNT UP". THE WHITEHALL REPRESENTATIVE ASKED HER IF THE UINIT HAD BEEN RUN DRY (WITHOUT WATER), TO WHICH SHE REPLIED "NO". SHE CONTINUED SAYING THAT THE FIRE DEPARTMENT HAD BEEN CALLED TO THE SCENE. SHE STATED SHE ORDER A REPLACEMENT UNIT. NO INFORMATION AS TO IF THE SPLINT PAN WAS A WHITEHALL UNIT NOR WAS ANY INFORMATION ON THE SERIAL NUMBER OR OTHER IDENTIFYING MARKINGS GIVEN. THE REPORTER DID NOT STATE THAT ANY INJURY OR ADVERSE EVENT OCCURRED.

    Description of Event or Problem · 1

    A WHITEHALL REPRESENTATIVE WAS AT A SHOW IN DALLAS. WHILE MANNING THE WHITEHALL BOOTH, A FEMALE APPROACHED THE WHITEHALL REP ABOUT A SPLINT PAN SHE HAD AN ISSUE WITH. THE FEMALE STATED THAT HER SPLINT PAN HAD BURNT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958086 WHITEHALL SPLINT PAN IRQ FABRICACION Y MANUFACTURAS DE MEXICO S.A. DE C.V. UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention