BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 9466086 · Received December 13, 2019

    Report

    Report Number
    9617229-2019-16037
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    August 15, 2019
    Report Date
    September 10, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE IDENTIFIED PHOTOS: DEVICE PATCH WITH LOT NUMBER 2100101, CREASE FOLD, WEAR ABRASION, AND APPARENTLY THE UNIT HAS AN OPENING AND LABELED AS RIGHT SIDE. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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. REASON FOR REOPERATION DUE TO DEFLATION. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A DEFLATION ON AN UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260745 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2100101

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention