BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 16782073 · Received April 20, 2023

    Report

    Report Number
    9617229-2023-06951
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 23, 2023
    Report Date
    August 9, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    UDI-DI
    10888628000599
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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, VISIBILITY/PALPABILITY.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: DEFLATION: OBSERVED AN OPENING ON POSTERIOR ASSESSED AS SURGICAL DAMAGE. CREASE/FOLDING OF IMPLANT: CREASE FLAT OBSERVED ON THE DEVICE. OTHER TECHNICAL: BROWN PARTICLES OBSERVED IN THE FILL CHANNEL. ADDITIONAL OBSERVATIONS: NO OTHER OBSERVATIONS OBSERVED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION AND VISIBLE FOLDING. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION AND VISIBLE FOLDING, "PARTICLES IN VALVE" VIA RGA. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PARTICLES IN VALVE" VIA RGA. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PARTICLES IN VALVE" VIA RGA. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936570 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 68LP-325 3578082 10888628000599

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention