BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 15986467 · Received December 15, 2022

    Report

    Report Number
    9617229-2022-23420
    Event Type
    Injury
    Date Received
    December 15, 2022
    Date of Event
    September 26, 2022
    Report Date
    November 14, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191601917
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF SEROMA-LATE 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: CONTRALATERAL RUPTURE.

    Additional Manufacturer Narrative · 0

    PHOTO EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: DEVICE PATCH WITH LOT NUMBER 3182154. CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. REFER TO PS-QP-ONEV-115717:COVID-19 QUALITY PLAN - COMPLAINT HANDLING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D6A.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT CAPSULAR CONTRACTURE BAKER GRADE I, "CREASE/FOLDS", AND "PERIPROSTHETIC LIQUID". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT CAPSULAR CONTRACTURE BAKER GRADE I, "CREASE/FOLDS", AND "PERIPROSTHETIC LIQUID". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT CAPSULAR CONTRACTURE BAKER GRADE I, "CREASE/FOLDS", AND "PERIPROSTHETIC LIQUID". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757721 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2547580 05060191601917

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention