BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPULSE SOLO

    MDR report key: 3001777 · Received February 7, 2013

    Report

    Report Number
    1213643-2013-00041
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Report Date
    January 10, 2013
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CANNOT BE CONFIRMED AT THIS TIME AS THE SAMPLE HAS NOT YET BEEN RETURNED FOR EVALUATION. THE LOT NUMBER HAS NOT BEEN PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE IFU CAUTIONS THAT PRODUCT IS STERILE UNLESS PACKAGE IS DAMAGED OR OPEN.

    Description of Event or Problem · 1

    INFORMATION AS REPORTED TO DAVOL: IT WAS REPORTED THAT THE GLUE ON PAPER OF THE TYVEK LID IS NOT STICKING, NOT STAYING CLOSED. THE DAMAGE WAS NOTED UPON RECEIPT OF THE PRODUCT AND THERE WAS NO PATIENT INTERVENTION. AS REPORTED, THIS MAY REPRESENT A BREACH OF STERILITY AS SUCH AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53213 SIMPULSE SOLO FQH DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1