BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMULA SHAVER HANDPIECE (WITH BUTTONS)

    MDR report key: 2182067 · Received June 23, 2011

    Report

    Report Number
    2936485-2011-00450
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT TURNS ON BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORMULA SHAVER HANDPIECE (WITH BUTTONS) SHAVER HANDPIECE HRX STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK