BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACX DOUBLE CHAMBER TISSUE EXPANDER

    MDR report key: 3213579 · Received July 3, 2013

    Report

    Report Number
    1651189-2013-00021
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    February 13, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SIENTRA, INC
    Product Code
    LCJ
    PMA / PMN Number
    K981852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEFT SIDE BREAST TISSUE EXPANDER REPORTED AS 'DEFECTIVE'. NO INFO REPORTED AS TO ALLEGED DEFECT, HOWEVER, TISSUE EXPANDER WAS REMOVED AND REPLACED WITH ANOTHER TISSUE EXPANDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303714 ACX DOUBLE CHAMBER TISSUE EXPANDER LCJ SIENTRA, INC 20799

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other