BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR LEFT BREAST TISSUE EXPANDER

    MDR report key: 4916390 · Received July 9, 2015

    Report

    Report Number
    MW5044179
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 26, 2015
    Report Date
    July 1, 2015
    Manufacturer
    MENTOR H/S CORP.
    Product Code
    LCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH HISTORY OF BREAST CA UNDERWENT BILATERAL MASTECTOMIES ON (B)(6) 2015 WITH IMMEDIATE RECONSTRUCTION: PLACEMENT OF TISSUE EXPANDERS AND FLEX HD. APPROXIMATELY 1 WK AGO PT DEVELOPED ERYTHEMA, SWELLING AND INCREASED PAIN IN THE LEFT BREAST RECONSTRUCTION. SHE WAS PLACED ON ORAL ANTIBIOTICS, WITH MINIMAL IMPROVEMENT. SHE HAD 2 JP DRAINS STILL IN PLACE. SHE WAS ADMITTED ON (B)(6) 2015 AND WAS TAKEN TO THE OPERATING ROOM FOR "EXPLORATION OF L BREAST RECONSTRUCTION, DRAINAGE OF ABSCESS, REMOVAL OF TISSUE EXPANDER, REMOVAL OF FLEX HD DEBRIDEMENT AND IRRIGATION". FINDINGS: INFECTION WAS NOTED TO BE SUPERFICIAL AND MAJORITY OF PURULENT MATERIAL APPEARED TO BE ABOVE AND IN THE SOFT TISSUE OF THE LATERAL BREAST RECONSTRUCTION. FLEX HD WAS MINIMALLY INCORPORATED; HAD NOT BEEN ATTACHED OR INCORPORATED TO THE SOFT TISSUE. JP DRAINS WERE CLIPPED AND REMOVED. WOUND WAS CURETTAGE THEN IRRIGATED WITH ANTIBIOTIC SOLUTION. NEW JP DRAINS WERE INSERTED. WOUND WAS CLOSED. PT TOLERATED THE PROCEDURE WELL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444700 MENTOR LEFT BREAST TISSUE EXPANDER BREAST TISSUE EXPANDER, LEFT LCJ MENTOR H/S CORP. 354-9213 6927074

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention