BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 19147029 · Received April 19, 2024

    Report

    Report Number
    9617229-2024-06816
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    March 12, 2024
    Report Date
    June 11, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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: DEFLATION.

    Additional Manufacturer Narrative · 0

    REPORTABLE EVENTS CAPTURED IN CONTRALATERAL DEVICE (RIGHT): MDR #9617229-2024-09921-00.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED RIGHT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. PHYSICIAN LATER REPORTED HOLE IN VALVE AND HOLE IN VALVE SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PREVIOUS MEDWATCH SUBMISSION NOTED DEFLATION. HEALTHCARE PROFESSIONAL LATER REPORTED DEVICE IN TACT UPON EXPLANT SURGERY. UPON FURTHER INFORMATION, ABBVIE HAS DETERMINED THAT THE EVENT OF DEFLATION DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408750 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1710456

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention