BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH)

    MDR report key: 1782142 · Received February 12, 2008

    Report

    Report Number
    1527736-2008-00819
    Event Type
    Malfunction
    Date Received
    February 12, 2008
    Report Date
    February 1, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K030925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER = BATCH NUMBER. DAMAGED KNIFE AND BREAKAWAY WASHER CUT OFF CENTER.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED WITH INFORMATION. THERE WAS NO REPORTED PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH) GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1