BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9511346 · Received December 23, 2019

    Report

    Report Number
    9617229-2019-18171
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    May 17, 2013
    Report Date
    December 23, 2019
    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 · 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. INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR 986670 ON 17/JUL/13. ADDITIONAL INFORMATION WAS SUBMITTED THROUGH PSR 1234132 ON 19/OCT/15. IN RESPONSE TO FDA REPORT NUMBER: MW5089983. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENTS OF "PAIN AND RAYNAUD'S PHENOMENON " 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: PAIN AND RUPTURE.

    Description of Event or Problem · 1

    PATIENT REPORTED RAYNAUD¿S PHENOMENON. PATIENT REPORTED MODERATE BREAST PAIN ON THE RIGHT SIDE. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304737 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1722516

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention