BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 19256074 · Received May 6, 2024

    Report

    Report Number
    9617229-2024-07809
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 26, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: DEFLATION- BREAST: OBSERVED, ONE OPENING ASSESSED AS CRACKED VALVE SEAT DIAPHRAGM VALVE. CREASE/ FOLDING OF IMPLANT-BREAST: OBSERVED, FLAT CREASES. USE ERROR: OBSERVED, ONE OPENING ASSESSED AS SURGICAL DAMAGE PER RGA. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, PATIENT WANTS TO "REPLACE THEM WITH NEW SALINE IMPLANTS". HEALTHCARE PROFESSIONAL, LATER REPORTED, "ANY CREASES, ALMOST COMPLETE DEFLATION". AND "INCISION IN SHELL TO DEFLATE AND MARKED AS INSTRUCTED". DEVICE WAS EXPLANTED. RECORD IS FOR LEFT SIDE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED PATIENT WANTS TO "REPLACE THEM WITH NEW SALINE IMPLANTS." HEALTHCARE PROFESSIONAL LATER REPORTED "ANY CREASES, ALMOST COMPLETE DEFLATION" AND "INCISION IN SHELL TO DEFLATE AND MARKED AS INSTRUCTED." DEVICE WAS EXPLANTED. RECORD IS FOR LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670451 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1796316

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention