BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE EXPANDER

    MDR report key: 3242714 · Received July 17, 2013

    Report

    Report Number
    MW5030966
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    July 15, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON REMOVED BREAST TISSUE EXPANDER, SAID IT WAS RUPTURED. REPLACED IT WITH ANOTHER EXPANDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331836 TISSUE EXPANDER TISSUE EXPANDER LCJ ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 POTASSIUM| VIT E| HCTZ 25MG| MULTIVITAMINS| TYLENOL 325MG| VALIUM 5MG| LASIX 40MG| ROBITUSSIN| DIPHENHYDRAMINE 25-50MG| B COMPLEX VITAMINS| PROBIOTIC PRODUCT| NYQUIL| CALCIUM 520MG| LISINOPRIL 10MG| VIT D