BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEST MODEL 105

    MDR report key: 2170041 · Received July 13, 2011

    Report

    Report Number
    3008145987-2011-00005
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    HILL-ROM SERVICES PRIVATE LIMITED
    Product Code
    BYI
    PMA / PMN Number
    K024309
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF THE DEVICE WAS ALLEGED NOR FOUND THROUGH THE ANALYSIS OF THE UNIT.

    Description of Event or Problem · 1

    HILL-ROM HAS REC'D A REPORT INDICATING THAT THE PT BELIEVED THE USE OF THE VAST MAY HAVE CONTRIBUTED TO HER RUPTURED BREAST IMPLANT. NO MALFUNCTION OF THE DEVICE WAS ALLEGED NOR FOUND THROUGH THE ANALYSIS OF THE UNIT.

    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 64 YR Required Intervention