BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAVA BRA

    MDR report key: 380305 · Received March 1, 2002

    Report

    Report Number
    MW1024232
    Event Type
    Other
    Date Received
    March 1, 2002
    Date of Event
    December 1, 2001
    Report Date
    March 1, 2002
    Manufacturer
    BRAVA, LLC
    Product Code
    KCZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BRAVA BRAS SELLS A CLASS 11 MEDICAL DEVICE TO ENLARGE BREASTS. A LOCAL DR AND RPTR BOTH TRIED IT AND BOTH DEVELOPED BLISTERS ON BREASTS. WHEN RPTR CALLED TO COMPLAIN THE PERSON WHO ANSWERED THE PHONE SAID THEY DID TOO. HOW CAN WE FORCE THE MFR TO WARN OR IMPROVE THIS PRODUCT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVA BRA BREAST ENLARGEMENT KCZ BRAVA, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other