BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 15204126 · Received August 10, 2022

    Report

    Report Number
    9617229-2022-13684
    Event Type
    Injury
    Date Received
    August 10, 2022
    Report Date
    September 2, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628001732
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIP CODE: (B)(6). (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. THE EVENT OF "SEROMA FLUID" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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 BREAST IS HARD" "RUPTURED IMPLANT".

    Additional Manufacturer Narrative · 0

    DEVICE PHOTO ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED; DEVICE PATCH WITH LOT NUMBER 3210979, DEFORMATION. 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

    PHYSICIAN REPORTED RIGHT SIDE INSUFFICIENT INFORMATION. PHYSICIAN LATER REPORTED RIGHT SIDE "RUPTURED IMPLANT" CONFIRMED VIA ULTRASOUND/MAMMOGRAPHY AND "PAIN AND BREAST IS HARD." DEVICE WAS EXPLANTED "INTACT." ADDITIONALLY REPORTED "SEROMA FLUID FROM RIGHT BREAST POCKET" FOUND INTRAOPERATIVELY.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED RIGHT SIDE INSUFFICIENT INFORMATION. PHYSICIAN LATER REPORTED RIGHT SIDE "RUPTURED IMPLANT" CONFIRMED VIA ULTRASOUND/MAMMOGRAPHY AND "PAIN AND BREAST IS HARD." DEVICE WAS EXPLANTED "INTACT." ADDITIONALLY REPORTED "SEROMA FLUID FROM RIGHT BREAST POCKET" FOUND INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786641 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 20-475 3210979 10888628001732

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention