BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEST, MODEL 105

    MDR report key: 2151500 · Received June 23, 2011

    Report

    Report Number
    1045510-2011-00019
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 24, 2011
    Manufacturer
    HILL-ROM SERVICES PRIVATE LIMITED
    Product Code
    BYI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HILL-ROM HAS RECEIVED A REPORT ALLEGING THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE BLACK FLOATERS DEVELOPING IN A PT'S EYE DURING TREATMENT. THE REPORT INDICATES THAT THE PT'S OPHTHALMOLOGIST DIAGNOSED THE PT WITH A VITREOUS TEAR. NO MALFUNCTION OF THE DEVICE WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEST, MODEL 105 POWERED PERCUSSOR BYI HILL-ROM SERVICES PRIVATE LIMITED 105 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other