BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYLISS MEDICAL GENERATOR AND PROBES REF # PMG 115 TD

    MDR report key: 1084316 · Received July 29, 2008

    Report

    Report Number
    MW5007831
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 28, 2008
    Manufacturer
    KIMBERLY CLARK
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BAYLESS MEDICAL GENERATOR MALFUNCTION: PROBES BAD. PROBES INJECTED INTO PATIENT'S 14/5 DISK ON THE RIGHT SIDE AND 14/5 DISK ON THE LEFT SIDE NEURAL FORAMINAL AREA. DID NOT FUNCTION. HAD TO BE REMOVED. PROCEDURE ABANDONED. PATIENT GIVEN IV ANCEF PRE PROCEDURE AND PO Z PACK POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAYLISS MEDICAL GENERATOR AND PROBES REF # PMG 115 TD PROBES GEI KIMBERLY CLARK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR