BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP S-9.0 TITANIUM

    MDR report key: 1810139 · Received August 17, 2010

    Report

    Report Number
    2647580-2010-00714
    Event Type
    Injury
    Date Received
    August 17, 2010
    Report Date
    August 16, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDO
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: TRAM FLAP. ACCORDING TO THE REPORTER: MALFORMED CLIP OCCURRED DURING THE CASE. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS NO ADDITIONAL BLEEDING. THE STAFF USED ANOTHER DEVICE TO CONTINUE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP S-9.0 TITANIUM DISPOSABLE CLIP APPLIER GDO USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability