BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 15999877 · Received December 16, 2022

    Report

    Report Number
    9617229-2022-22695
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    August 15, 2019
    Report Date
    July 31, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: DEFLATION: OBSERVED CREASE SHARP OPENING ON RADIUS ASSESSED AS FOLD FLAW OPENING. THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION WAS RECEIVED ON JUNE 29, 2023, WITH CATALOG NUMBER MCGHAN390CC. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: DEFLATION: OBSERVED CREASE SHARP OPENING ON RADIUS ASSESSED AS FOLD FLAW OPENING. ADDITIONAL OBSERVATIONS: CREASE FOLD OBSERVED. STRESS MARKS OBSERVED. BROWN PARTICLES INSIDE OF THE DEVICE. WEAR ABRASION OBSERVED. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED. ADDITIONAL OBSERVATIONS: CREASE FOLD OBSERVED. STRESS MARKS OBSERVED. BROWN PARTICLES INSIDE OF THE DEVICE. WEAR ABRASION OBSERVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED PATIENT HAS A DEFLATION ON ONE SIDE, POSSIBLY BOTH BUT DEFINITELY THE ONE SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED PATIENT HAS A DEFLATION ON ONE SIDE, POSSIBLY BOTH BUT DEFINITELY THE ONE SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2097745 UNK SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention