BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH)

    MDR report key: 1823814 · Received December 3, 2007

    Report

    Report Number
    1527736-2007-08222
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Report Date
    November 14, 2007
    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 Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STARR PROCEDURE, THE DEVICE DELIVERED AN INCOMPLETE STAPLE LINE. NO FURTHER INFORMATION IS AVAILABLE. COMPLETED WITH THE SAME LIKE PRODUCT. THERE WAS NO PATIENT 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