BEUDAMED
    FDA Adverse Event Summary report: N

    VIP

    MDR report key: 1842771 · Received September 10, 2010

    Report

    Report Number
    1842771
    Date Received
    September 10, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 27, 2010
    Manufacturer
    VANARSDALE INNOVATIVE PRODUCTS INC.
    Product Code
    HEF
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT GOT A BURN BELOW LEFT BREAST FROM CUSTOM BREAST SUPPORT REMAINING TOO HOT. IT IS BELIEVED THAT THE SPONGE FRAME CONTAINED TOO MUCH HOT WATER.====================== HEALTH PROFESSIONAL'S IMPRESSION======================HOT WATER IS NECESSARY TO FORM THE BREAST SUPPORT. THE HOT WATER MAY NOT HAVE BEEN ENTIRELY SQUEEZED OUT OF SPONGE FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIP CUSTOM BREAST SUPPORT HEF VANARSDALE INNOVATIVE PRODUCTS INC. VIP-CBS-11 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR