BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 16269302 · Received January 30, 2023

    Report

    Report Number
    9617229-2023-01890
    Event Type
    Injury
    Date Received
    January 30, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: ¿WE HAVE A PATIENT WHO HAS A RUPTURED IMPLANT AND IS ENQUIRING ABOUT WARRANTY INFORMATION. CAN SOMEONE PLEASE CONTACT OUR ROOMS?¿

    Description of Event or Problem · 0

    PHYSICIAN REPORTED UNKNOWN SIDE, "RUPTURED IMPLANT". DEVICE STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789194 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention