BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 11996184 · Received June 14, 2021

    Report

    Report Number
    9617229-2021-07579
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    December 15, 2020
    Report Date
    October 5, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHYSICIAN FURTHER CONFIRMS "CURRENTLY, THERE IS NO ACTUAL EVIDENCE OF ALCL". PHYSICIAN NOTED "THE LAST ASPIRATION OF FLUID DID NOT YIELD MUCH SAMPLE (FOR CD31 CELLS) AND WHEN IT WAS ANALYZED, THEY WERE NOT ABLE TO DETECT ANY SUSPICIOUS CELLS...THE FLUID AROUND THE IMPLANT WAS MINIMAL AND THAT THERE WERE NO CONCERNING FEATURES ON SCAN AND CLINICAL EXAMINATION." PATIENT ADDITIONALLY REPORTED "RIGHT BREAST HAD BECOME QUITE SWOLLEN AND LUMPY," PHYSICIAN "FOUND SOME FLUID WHICH WAS DRAINED AND SENT FOR CHECKING TO RULE OUT LYMPHOMA," FEELING "WORRY AND THE STRESS OF POSSIBLY HAVING LYMPHOMA," "BREASTS WERE EXTREMELY ODD LOOKING, SWOLLEN, ONE WAS MORE ELEVATED THAT THE OTHER AND THEY WERE QUITE PAINFUL." THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED PATIENT HAS ASPIRATION SENT FOR ALCL TESTING. PATIENT ADDITIONALLY REPORTED "PAIN AND SWELLING" OF THE RIGHT BREAST. THE DEVICE REMAINS IMPLANTED. PHYSICIAN FURTHER CONFIRMS "CURRENTLY, THERE IS NO ACTUAL EVIDENCE OF ALCL". PHYSICIAN NOTED "THE LAST ASPIRATION OF FLUID DID NOT YIELD MUCH SAMPLE (FOR CD31 CELLS) AND WHEN IT WAS ANALYZED, THEY WERE NOT ABLE TO DETECT ANY SUSPICIOUS CELLS.THE FLUID AROUND THE IMPLANT WAS MINIMAL AND THAT THERE WERE NO CONCERNING FEATURES ON SCAN AND CLINICAL EXAMINATION." PATIENT ADDITIONALLY REPORTED "RIGHT BREAST HAD BECOME QUITE SWOLLEN AND LUMPY," PHYSICIAN "FOUND SOME FLUID WHICH WAS DRAINED AND SENT FOR CHECKING TO RULE OUT LYMPHOMA," FEELING "WORRY AND THE STRESS OF POSSIBLY HAVING LYMPHOMA," "BREASTS WERE EXTREMELY ODD LOOKING, SWOLLEN, ONE WAS MORE ELEVATED THAT THE OTHER AND THEY WERE QUITE PAINFUL." THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    THE EVENT OF SEROMA-LATE 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: SEROMA, PAIN, SWELLING.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED PATIENT HAS ASPIRATION SENT FOR ALCL TESTING. PATIENT ADDITIONALLY REPORTED "PAIN AND SWELLING" OF THE RIGHT BREAST. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886344 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention