BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIVIEW

    MDR report key: 7000457 · Received November 3, 2017

    Report

    Report Number
    1220984-2017-00128
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    October 9, 2017
    Report Date
    October 11, 2017
    Product Code
    LIZ
    UDI-DI
    15420045504684
    PMA / PMN Number
    K132136
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WASN'T MADE AVAILABLE TO EVALUATE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENT WILL BE FILED.

    Description of Event or Problem · 1

    ON OCT. 11, 2017, CUSTOMER REPORTED THAT DURING A BIOPSY PROCEDURE THE PATIENT HAD A RUPTURE OF THE GEL SILICONE IMPLANT. WE WERE UNABLE TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779637 MULTIVIEW MULTIVIEW LIZ MVM-HW-LT-01 N/A 15420045504684

    Patients

    Seq Age Sex Outcome Treatment
    1 Other