BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 17951304 · Received October 17, 2023

    Report

    Report Number
    9617229-2023-31185
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    September 10, 2023
    Report Date
    December 28, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    UDI-DI
    10888628000193
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION WAS RECEIVED ON NOVEMBER 13, 2023, WITH LOT NUMBER 1121227. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: DEFLATION: OBSERVED OPENING ASSESSED AS UNIDENTIFIED (TEAR) OPENING (NO SHELL THICKNESS DUE TO OPENING IS UNDER PLUG STRAP). ADDITIONAL OBSERVATIONS: NO OTHER OBSERVATION OBSERVED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO MANUFACTURING ISSUE IS OBSERVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89617 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1121227 10888628000193

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention