BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 18681639 · Received February 9, 2024

    Report

    Report Number
    9617229-2024-02311
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    January 9, 2024
    Report Date
    February 9, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED PHONE NUMBERS (E.1): (B)(6); FAX: +972-3-697-3890. THE EVENT OF WOUND DEHISCENCE 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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: PATIENT DEVELOPED WOUND DEHISCENCE. ARTICLE CITATION: SHOHAM, GON, ET AL. "OUR EXPERIENCE IN DIAGNOSING AND TREATING BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL)." JOURNAL OF CLINICAL MEDICINE, VOL. 13, ISSUE 2, 9 JAN. 2024, PP. 366., HTTPS://DOI.ORG/10.3390/JCM13020366.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE, "OUR EXPERIENCE IN DIAGNOSING AND TREATING BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL)", A "PATIENT UNDERWENT A PROPHYLACTIC RISK-REDUCING SALPINGO-OOPHORECTOMY AND A BILATERAL SKIN-SPARING MASTECTOMY FOLLOWED BY IMMEDIATE RECONSTRUCTION WITH BIOCELL® IMPLANTS . . . SHORTLY AFTERWARD, [THE PATIENT] DEVELOPED ... WOUND DEHISCENCE. THE PATIENT "UNDERWENT THE DEBRIDEMENT AND IRRIGATION OF THE WOUNDS". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED AND EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379805 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention