BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, ASPIRATION NEEDLE-NO REP.

    MDR report key: 1872725 · Received October 12, 2010

    Report

    Report Number
    2936485-2010-00757
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 20, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD OF THE UNIT RUPTURED DURING THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKG, ASPIRATION NEEDLE-NO REP. NEEDLE EOQ STRYKER ENDOSCOPY SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK