BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTORAL STYLE 2 SIZE 2 RIGHT

    MDR report key: 19616832 · Received June 26, 2024

    Report

    Report Number
    3003897287-2024-50001
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    May 29, 2024
    Report Date
    June 25, 2024
    Manufacturer
    DSAART, LLC
    Product Code
    MIC
    PMA / PMN Number
    KO21337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    REPORTED TEAR IN IMPLANT. LATER IMAGING CONFIRMED TEAR IN IMPLANT. EXPLANT NOT SCHEDULED. INVESTIGATION WILL BE CONDUCTED ONCE IMPLANT IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549555 PECTORAL STYLE 2 SIZE 2 RIGHT Implant, muscle, pectoralis MIC DSAART, LLC 20-07-019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown