BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFESTEP 22GX3/4

    MDR report key: 1292029 · Received January 16, 2009

    Report

    Report Number
    3006260740-2009-00024
    Event Type
    Injury
    Date Received
    January 16, 2009
    Date of Event
    October 15, 2008
    Report Date
    December 22, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    FPA
    PMA / PMN Number
    K040527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVALUATION. A CHR REVIEW SHOWED FOUR OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT. (196839, 196841, 196843 AND 202879).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESTEP 22GX3/4 FPA C. R. BARD INC. (BASD) D815822

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention