BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 9884754 · Received March 26, 2020

    Report

    Report Number
    9617229-2020-04756
    Event Type
    Injury
    Date Received
    March 26, 2020
    Report Date
    April 23, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND "WHEN LAYING DOWN THE IMPLANTS MIGRATE UNDER HER ARMS", AND "IF LAYING FLAT ON HER BACK THERE IS A BIG GAP IN HER IMPLANTS AND HER NIPPLES ARE TURNING DOWNWARD". PATIENT ADDITIONALLY REPORTED "TOTALLY FLATTENED, LOOKED SMALLER, JUST ABOUT GONE AND A RASH UP MY CHEST AND NECK" AND "FACE SWOLLEN FROM EYES DOWN" - NOT RELATED TO THE DEVICE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND "WHEN LAYING DOWN THE IMPLANTS MIGRATE UNDER [THEIR] ARMS", AND "IF LAYING FLAT ON [THEIR] BACK THERE IS A BIG GAP IN [THE] IMPLANTS AND NIPPLES ARE TURNING DOWNWARD". DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348217 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2448030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention