BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACX DOUBLE CHAMBER TISSUE EXPANDER

    MDR report key: 3133386 · Received May 24, 2013

    Report

    Report Number
    1651189-2013-00013
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    January 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SIENTRA, INC
    Product Code
    LCJ
    PMA / PMN Number
    K981852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEFT-SIDE BREAST TISSUE EXPANDER REPORTED DEFLATION. EXPLANTATION AND REPLACEMENT WITH IDENTICAL BREAST TISSUE EXPANDER FOR CONTINUATION OF TREATMENT (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231819 ACX DOUBLE CHAMBER TISSUE EXPANDER LCJ SIENTRA, INC 20799

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other