BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.25CM ATTACHMENT, BLACK MAX

    MDR report key: 2883162 · Received December 18, 2012

    Report

    Report Number
    1045834-2012-00133
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HSZ
    PMA / PMN Number
    K955084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "HEATING UP" DURING PRETESTING. THERE WAS NO PT INVOLVEMENT OR INJURIES REPORTED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.25CM ATTACHMENT, BLACK MAX HSZ THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1