BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 11744684 · Received April 29, 2021

    Report

    Report Number
    9617229-2021-07014
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    November 25, 2008
    Report Date
    September 21, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE RIGHT SIDE DEVICE WAS CONFIRMED AS INTACT.

    Additional Manufacturer Narrative · 1

    INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH ASR ON 10MAY2012. 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. DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CREASE FOLD, OPENING ON ANTERIOR, AND WEAR ABRASION. A LEAK TEST WAS PERFORMED AND FOUND AN OPENING ON ANTERIOR SIDE. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFY A STRIATED EDGE OPENING, CONSIST WITH USE OF A SURGICAL TOOL. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS A STRIATED EDGE OPENING ON THE ANTERIOR SIDE DUE TO SURGICAL DAMAGE. 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 III, AND DEFLATION. 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.

    Description of Event or Problem · 1

    PATIENT REPORTED RIGHT SIDE "LUMP OR THICKENING IN OR NEAR THE BREAST OR IN THE UNDERARM AREA." NO INDICATION TREATMENT OR SURGICAL REOPERATION HAS OCCURRED. HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645367 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1514092

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention