BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIWAND II 5MM W/CAUT/L-HOOK/TUBE/GFS

    MDR report key: 1971824 · Received January 5, 2011

    Report

    Report Number
    2647580-2010-01019
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Report Date
    December 7, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    HET
    PMA / PMN Number
    K903207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER SUBMITTED A COPY OF THIS REPORT TO FDA VIA REPORT NUMBER (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIWAND II 5MM W/CAUT/L-HOOK/TUBE/GFS DISPOSABLE SURGICAL DEVICE HET USSC PUERTO RICO P0J0268L

    Patients

    Seq Age Sex Outcome Treatment
    1