BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 10082744 · Received May 22, 2020

    Report

    Report Number
    9617229-2020-07987
    Event Type
    Injury
    Date Received
    May 22, 2020
    Date of Event
    April 6, 2020
    Report Date
    September 11, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF BECOMING AWARE. RECENT STIMULATED REPORTING RELATED TO 2011068-7/2/19-001-R HAS INCREASED COMPLAINT AND MDR VOLUME. ALLERGAN IS IMPLEMENTING A PLAN TO ADDRESS THE INCREASED VOLUMES. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: VISUAL ANALYSIS OF THE IDENTIFIED PHOTOS WHITE PARTICLES INNER THE SHELL, DEVICE LABELED AS LEFT SIDE, AND NO OPENING OBSERVED. UNABLE TO IDENTIFY ANY UNIQUE AND/OR UNUSUAL OBSERVATIONS OF THE DEVICE.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: DEFLATION. ALLERGAN IS NOT REQUESTING THE DEVICE RETURN AT THIS TIME DUE TO GLOBAL SAFETY CONCERNS ASSOCIATED WITH COVID-19.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547136 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1800549

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention