BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 9566607 · Received January 8, 2020

    Report

    Report Number
    9617229-2019-22831
    Event Type
    Injury
    Date Received
    January 8, 2020
    Report Date
    October 16, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    UDI-DI
    10888628000452
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED. DEVICE PATCH WITH LOT (OR CATALOG) NUMBER: LOT NUMBER: 3012112 AND CATALOG NUMBER: 68HP-550. A DEFLATED SALINE DEVICE IS OBSERVED BUT DUE TO THE QUALITY OF THE PHOTOS IT CANNOT BE DETERMINED IF THERE MAY BE AN OPENING. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27918 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 68HP-550 3012112 10888628000452

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention