BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14986091 · Received July 12, 2022

    Report

    Report Number
    9617229-2022-11385
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    June 13, 2022
    Report Date
    September 21, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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: RUPTURE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: OPENING, UNDERWEIGHT, BROKEN SHELL, CREASE FOLD, WEAR ABRASION. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFY SHARP EDGE AND WITH NON-PENETRATING NICKS ASSESSED AS SURGICAL IMPACT OPENING. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFY THE THICKNESS WITHIN SPECIFICATION. STRESS MARK. AND ALSO IDENTIFY A SHARP EDGE OPENING ASSESSED AS UNIDENTIFIED TEAR OPENING. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFY THE THICKNESS WITHIN SPECIFICATION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A SHARP EDGE OPENING WITH NON-PENETRATING NICKS ASSESSED AS SURGICAL IMPACT. NON-PENETRATING NICKS. A SHARP OPENING ON RADIUS ASSESSED AS UNIDENTIFIED (TEAR) OPENING.

    Description of Event or Problem · 0

    MEDICAL STAFF REPORTED RUPTURE AGAINST RIGHT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    MEDICAL STAFF REPORTED RUPTURE AGAINST RIGHT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    MEDICAL STAFF, ON BEHALF OF PHYSICIAN, REPORTED RUPTURE AGAINST RIGHT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670274 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2165579

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention