BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9469759 · Received December 13, 2019

    Report

    Report Number
    9617229-2019-21499
    Event Type
    Injury
    Date Received
    December 13, 2019
    Report Date
    December 13, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO FDA REPORT NUMBER: MW5090834. 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 CAPSULAR CONTRACTURE 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: CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN.

    Description of Event or Problem · 1

    PATIENT REPORTED VIA REGULATORY AGENCY "¿SWELLING OFF AND ON¿, ¿"EXTREME DISCOMFORT WEARING BRAS AND BY MID AFTERNOON I WOULD SWELL WEARING THEM. BRAS BECAME SO UNBEARABLE I QUIT WEARING DUE TO INCREASED SWELLING, PAIN", ¿RUINED 4 BRAS BECAUSE THE IMPLANTS WERE SO HARD THEY BENT THE UNDERWIRE¿, "SEVERE CAPSULAR CONTRACTURE", ¿HAD TO REMOVE THE IMPLANT CLEAN OUT SCAR TISSUE AND REINSERT¿, ¿EXTREME DISCOMFORT WEARING BRAS¿, ¿IT WAS SO PAINFUL¿, ¿WHEN MY PS MANIPULATED IT BROUGHT TEARS TO MY EYES¿, ¿CONSTANT PAIN¿. PATIENT ADDITIONALLY REPORTED ¿UNBEARABLE ITCHING", NOT RELATED TO THE DEVICE. THIS RECORD REPRESENTS THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262620 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1816222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention