BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEST, MODEL 105

    MDR report key: 2150493 · Received June 23, 2011

    Report

    Report Number
    3008145987-2011-00003
    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
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF THE DEVICE WAS ALLEGED - THE UNIT HAS NOT BEEN RETURNED TO HILL-ROM.

    Description of Event or Problem · 1

    HILL-ROM HAS RECEIVED A REPORT ALLEGING THAT THE DEVICE MAY HAVE CONTRIBUTED TO BLACK FLOATERS DEVELOPING IN THE PATIENT'S EYE DURING TREATMENT. THE REPORT INDICATES THAT THE PATIENT'S OPHTHALMOLOGIST DIAGNOSED THE PATIENT WITH A VITREOUS TEAR. NO MALFUNCTION OF THE DEVICE WAS ALLEGED. THE DEVICE HAS NOT BEEN RETURNED TO HILL-ROM.

    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