BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 17060068 · Received June 5, 2023

    Report

    Report Number
    9617229-2023-09120
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    December 15, 2022
    Report Date
    August 25, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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, ANXIETY PRODUCT/PROCEDURE.

    Additional Manufacturer Narrative · 0

    BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ DEFLATION: OBSERVED DELAMINATION TOTAL OF THE VALVE (ADHESIVE FAILURE) ¿ ANXIETY-PRODUCT/PROCEDURE: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. ¿ VARIED INJURIES-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ OTHER MEDICAL-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ INFECTION (EARLY ONSET): UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. ¿ LUMP/NODULE-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: ¿ YELLOW BIOLOGICAL TISSUE OBSERVED ON THE DEVICE. ¿ OBSERVED BROKEN ON PLUG STRAP SIDE ASSESSED AS UNIDENTIFIED (TEAR) OPENING. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED "A RIGHT SIDE DEFLATION" AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." PATIENT ALSO REPORTED A RIGHT SIDE "WEIGHT GAIN, JOINT PROBLEMS, THYROID ISSUES, HASHIMOTO'S DISEASE" WHICH ARE NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE "HX R INFECTION" AND "IMPLANT COMPLETELY DEFLATED WITH ADHERENT CAPSULE". HEALTHCARE PROFESSIONAL ALSO REPORTED "HX R PHYLLODES TUMOR EXCISION" WHICH IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED "A RIGHT SIDE DEFLATION" AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." PATIENT ALSO REPORTED A RIGHT SIDE "WEIGHT GAIN, JOINT PROBLEMS, THYROID ISSUES, HASHIMOTO'S DISEASE" WHICH ARE NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE "HX R INFECTION" AND "IMPLANT COMPLETELY DEFLATED WITH ADHERENT CAPSULE". HEALTHCARE PROFESSIONAL ALSO REPORTED "HX R PHYLLODES TUMOR EXCISION" WHICH IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31249 UNK SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention