BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPULSE SOLO

    MDR report key: 1120108 · Received August 14, 2008

    Report

    Report Number
    1213643-2008-00405
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FQH
    PMA / PMN Number
    K942886
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A DEVICE WAS PULLED FOR A CASE AND AN UNFAMILIAR SUBSTANCE WAS NOTICED COMING OUT OF THE HANDPIECE AND IN THE TUBING. IT WAS TRACED TO THE BATTERY PACK AND A CORRODED BATTERY WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPULSE SOLO FQH DAVOL INC., SUB. C.R. BARD, INC. NA JUSEF242

    Patients

    Seq Age Sex Outcome Treatment
    1