BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP M-9.75 TITANIUM

    MDR report key: 2142833 · Received June 21, 2011

    Report

    Report Number
    2647580-2011-00390
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    FZP
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: FISTULA. ACCORDING TO THE REPORTER: THE CLIP APPLIER WAS PLACED AROUND VESSEL. THE CLIP DID NOT FORM AND VESSEL WAS CUT. UNANTICIPATED BLOOD LOSS OCCURRED DUE TO VESSEL BEING CUT. THE BLOOD LOSS WAS NOT MORE THAN 250CC. A SECOND CLIP APPLIER WAS OPENED AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP M-9.75 TITANIUM DISPOSABLE CLIP APPLIER FZP USSC PUERTO RICO P1C0307

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability