BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK STYLE SCL

    MDR report key: 19554505 · Received June 17, 2024

    Report

    Report Number
    9617229-2024-15290
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    May 22, 2024
    Report Date
    August 2, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: CAPSULAR CONTRACTURE BAKER GRADE 3, RUPTURE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL ALSO REPORTED CAPSULAR CONTRACTURE BAKER GRADE 3. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    IT HAS BEEN DETERMINED THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT IS NOT MANUFACTURED BY ALLERGAN. THIS RECORD IS NO LONGER REPORTABLE TO THE FDA AND WILL BE UN-REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687578 UNK STYLE SCL PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention