BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 17827718 · Received September 27, 2023

    Report

    Report Number
    9617229-2023-15536
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    September 5, 2023
    Report Date
    November 20, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION AND OTHER-TECHNICAL WAS RECEIVED ON OCT 17, 2023. WITH LOT NUMBER#: 1862127. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: DEFLATION: OBSERVED, ONE OPENING ON THE DIAPHRAGM VALVE SIDE ASSESSED, AS CRACKED VALVE SEAT DIAPHRAGM VALVE. ONE OPENING ON THE RADIUS SIDE ASSESSED, AS SURGICAL DAMAGE. AND PARTIAL DELAMINATION ON THE VALVE SIDE ASSESSED, AS ADHESIVE FAILURE. OTHER -TECHNICAL: NO OBSERVED, PARTICLES ON THE VALVE. ADDITIONAL OBSERVATIONS: CREASE OBSERVED, ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED, AS NO ISSUES WITH THE MANUFACTURING PROCESS ARE OBSERVED.

    Additional Manufacturer Narrative · 0

    CONTINUED H6 HEALTH EFFECT IMPACT CODE: F2203- IMAGING REQUIRED. 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 · 0

    PHYSICIAN REPORTED, A RIGHT SIDE DEFLATION. AND PARTICLES IN VALVE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED A RIGHT SIDE DEFLATION AND¿ PARTICLES IN VALVE ¿. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776468 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1862127

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention