BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT CONTROL, SC2100

    MDR report key: 2980128 · Received February 21, 2013

    Report

    Report Number
    1045834-2013-00301
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADD'L 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'S "PRONGS WERE BENT." THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO INJURIES REPORTED. THE DATE OF THE EVENT WAS NOT REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76503 FOOT CONTROL, SC2100 HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1