BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12722374 · Received October 29, 2021

    Report

    Report Number
    9617229-2021-56291
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    May 19, 2012
    Report Date
    May 9, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PHOTO EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: BROKEN SHELL. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM A FURTHER ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE "RIPPLING AND FEELS LIKE THEY MAY BE LEAKING", "ANXIETY", AND "CAPSULAR CONTRACTURE BAKER GRADE IV". HEALTHCARE PROFESSIONAL REPORTED "RIPPLING", "INCORRECT IMPLANT POSITION", "DOCTOR DID NOT SUSPECT OR CONFIRM A RUPTURE ", "PALPABILITY OF IMPLANT RIPPLES", AND "THEY ARE CLOSE TOGETHER". HEALTHCARE PROFESSIONAL REPORTED RUPTURE DURING SURGERY. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR ON 10/16/2012, 01/23/2013, 04/23/2013. 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. THE EVENTS OF WRINKLING AND CAPSULAR CONTRACTURE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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: "ANXIETY" AND CAPSULAR CONTRACTURE BAKER GRADE IV.

    Description of Event or Problem · 1

    PATIENT REPORTED LEFT SIDE "RIPPLING AND FEELS LIKE THEY MAY BE LEAKING", "ANXIETY", AND "CAPSULAR CONTRACTURE BAKER GRADE IV". HEALTHCARE PROFESSIONAL REPORTED "RIPPLING", "INCORRECT IMPLANT POSITION", "DOCTOR DID NOT SUSPECT OR CONFIRM A RUPTURE ", "PALPABILITY OF IMPLANT RIPPLES", AND "THEY ARE CLOSE TOGETHER". DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620739 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2229332

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention