BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENA MUSCLE STIMULATOR PROBE

    MDR report key: 2152385 · Received June 22, 2011

    Report

    Report Number
    9612007-2011-00025
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    INTEGRA, BIOT
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    PS2P/ PENA MUSCLE STIMULATOR PROBES WERE REPORTED TO HAVE "BROKEN" (UNSPECIFIED) AND WERE NOT USABLE. ONE PROBE WAS DISMANTLED AND PART OF THE COPPER CABLING INSIDE THE INSULATED SHEATH WAS FOUND TO BE BLACK. THE PROBES ALL CAME IN CONTACT WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENA MUSCLE STIMULATOR PROBE PENA STIMULATOR PROBE IPF INTEGRA, BIOT

    Patients

    Seq Age Sex Outcome Treatment
    1