BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENTOR BREAST TISSUE EXPANDER

    MDR report key: 19962691 · Received August 9, 2024

    Report

    Report Number
    MW5158321
    Event Type
    Other
    Date Received
    August 9, 2024
    Manufacturer
    MENTOR WORLDWIDE, LLC
    Product Code
    LCJ
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ALLEGED EVENT: HEALTHCARE PROFESSIONAL REPORTED VIA SUS VOLUNTARY MEDWATCH (UF/IMPORTER REPORT: #(B)(4)) RIGHT SIDE "FIVE PATIENTS WITH MENTOR BREAST TISSUE EXPANDERS DEVELOPED INFECTIONS AFTER SURGERY. DUCTAL CARCINOMA IN SITU OF RIGHT BREAST. RECONSTRUCTION OF BOTH BREASTS WITH TISSUE EXPANDER (MENTOR 450 ML WITH 0 INITIAL FILL), AND BILATERAL MASTECTOMY. PATIENT PRESENTS TO OFFICE APPOINTMENT FOR FILL AT BREAST CLINIC BUT LEFT BREAST IS WARM, RED SO SENT TO ED ON [DATE REMOVED]. LEFT BREAST TISSUE EXPANDER REMOVED IN OR ON [DATE REMOVED]." OF A (B)(6) DEVICE. DEVICE WAS EXPLANTED. ALLERGAN INC. ((B)(6) REF (B)(4)). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491923 MENTOR BREAST TISSUE EXPANDER TISSUE EXPANDER AND ACCESSORIES LCJ MENTOR WORLDWIDE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown