BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 18950829 · Received March 21, 2024

    Report

    Report Number
    9617229-2024-04842
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    February 26, 2024
    Report Date
    May 25, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE IS RELATED TO THE REPORTED EVENT DEFLATION RECEIVED ON APRIL 04, 2024, WITH LOT NUMBER 3022328. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: DEFLATION: OBSERVED 1 OPENING ASSESSED AS SURGICAL DAMAGE. NO OTHER OBSERVATIONS OBSERVED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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 · 0

    HEALTHCARE PROVIDER REPORTED A RIGHT SIDE DEFLATION. THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER REPORTED A RIGHT SIDE DEFLATION. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531911 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 3022328

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention