BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9865299 · Received March 23, 2020

    Report

    Report Number
    9617229-2020-06082
    Event Type
    Injury
    Date Received
    March 23, 2020
    Date of Event
    February 22, 2020
    Report Date
    July 21, 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

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT RUPTURE AND SEROMA-LATE WAS RECEIVED ON JUNE 15, 2020 WITH LOT NUMBER 2230350. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: UNDERWEIGHT, BROKEN SHELL AND BROWN PARTICLES IN THE SHELL. A VISUAL AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: SHARP BROKEN AND MISSING SHELL (0-25%). 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 BROKEN ON POSTERIOR ASSESSED AS AN UNIDENTIFIED (TEAR) OPENING. MISSING SHELL ASSESSED AS INCONCLUSIVE. REASON FOR REOPERATION: RUPTURE.

    Description of Event or Problem · 0

    PATIENT REPORTED ¿RIGHT SIDE RUPTURE" AND "SEROMA". LATER CONFIRMED NO CAPSULAR CONTRACTURE ON THIS SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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 CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND SEROMA-LATE 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: CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND SEROMA-LATE

    Description of Event or Problem · 1

    PATIENT REPORTED ¿RIGHT SIDE RUPTURE" AND "SEROMA" BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332336 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2230350

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention