BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE SILICONE-FILLED BREAST IMPLANT

    MDR report key: 8744100 · Received June 27, 2019

    Report

    Report Number
    MW5087677
    Event Type
    Injury
    Date Received
    June 27, 2019
    Report Date
    June 25, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REOCCURRING INFECTIONS (UTI, YEAST, BACTERIAL VAGINOSIS), HIVES, INTOLERANCE TO COLD. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531759 NATRELLE SILICONE-FILLED BREAST IMPLANT PROSTHESIS, BREAST, NON-INFLATABLE , INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN
    531760 NATRELLE SILICONE-FILLED BREAST IMPLANT PROSTHESIS, BREAST, NON-INFLATABLE , INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability