BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE INJECTION

    MDR report key: 3052704 · Received April 5, 2013

    Report

    Report Number
    MW5029690
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 5, 2013
    Manufacturer
    UNK
    Product Code
    KGM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED SILICONE INJECTIONS TO BUTTOCK AREA. DEVELOPED ALVEOLAR HEMORRHAGE WHICH REQUIRED ICU ADMISSION TO (B)(6) NOW ON DAY 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139933 SILICONE INJECTION SILICONE INJECTION KGM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| S