BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM ANGLE ATTACHMENT

    MDR report key: 2915630 · Received January 10, 2013

    Report

    Report Number
    1045834-2013-00069
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT ¿THE QD8 ATTACHMENT GETS HOT.¿ THE EVENT DID NOT OCCUR DURING SURGERY. THE DEVICE WAS FOUND TO GET HOT DURING TESTING. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13835 8CM ANGLE ATTACHMENT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1