BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9610295 · Received January 21, 2020

    Report

    Report Number
    9617229-2019-20723
    Event Type
    Injury
    Date Received
    January 21, 2020
    Date of Event
    July 15, 2010
    Report Date
    April 22, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON (B)(6) 2020 WITH LOT NUMBER 1850503. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEIGHT TO THE SPEC, RED PARTICLES IN THE SHELL, CREASE FOLD AND OPENING ON ANTERIOR. A VISUAL AND MICRO ANALYSIS WAS PERFORMED WHICH IDENTIFIED CREASED SHARP OPENING, STRESS MARKS AND WEAR ABRASION. BASE ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A OPENING CREASE SHARP ON ANTERIOR ASSESSED AS A FOLD FLAW OPENING. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D10, G1, H3, H6.

    Description of Event or Problem · 0

    PATIENT REPORTED UNKNOWN SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

    Additional Manufacturer Narrative · 1

    ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF BECOMING AWARE. RECENT STIMULATED REPORTING RELATED TO 2011068-7/2/19-001-R HAS INCREASED COMPLAINT AND MDR VOLUME. ALLERGAN IS IMPLEMENTING A PLAN TO ADDRESS THE INCREASED VOLUMES. 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.

    Description of Event or Problem · 1

    PATIENT REPORTED UNKNOWN SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76630 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1850503

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention