BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 10 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12216953 · Received July 23, 2021

    Report

    Report Number
    9617229-2021-48256
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    June 17, 2021
    Report Date
    September 30, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON AUGUST 12, 2021 WITH LOT NUMBER 1822136. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THE DEVICE WAS BROKEN SHELL, MISSING SHELL AND DARK RING. A WEIGHT TEST OF THE DEVICE WAS VERIFIED AND THE DEVICE UNDERWEIGHT. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED ONE SHARP EDGE BROKEN IN THE SHELL WITH STRESS MARKS. 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 BROKEN IN THE SHELL WITH STRESS MARKS IN THE SIDE RADIUS ASSESSED AS SURGICAL IMPACT OPENING. MISSING SHELL ASSESSED AS INCONCLUSIVE. PHOTO EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED; DEVICE PATCH WITH LOT NUMBER 1822136 AND AN EXTENDED OPENING. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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.

    Description of Event or Problem · 1

    PATIENT REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114275 STYLE 10 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1822136

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention