BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5FR DL POWERPICC BASIC WITH MI AND TLS

    MDR report key: 2960248 · Received February 8, 2013

    Report

    Report Number
    3006260740-2013-00054
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 31, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K060341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REWJ0604 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FORM THIS LOT NUMBER.

    Description of Event or Problem · 1

    HOSPITAL HAD INCIDENT WERE THE TIP OF THE WIRE CAME LOOSE AND WAS IMPLANTED INTO A PT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53512 5FR DL POWERPICC BASIC WITH MI AND TLS FOZ C. R. BARD INC. (BASD) REWJ0604

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention