BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURETTE

    MDR report key: 21572657 · Received March 11, 2025

    Report

    Report Number
    21572657
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 7, 2025
    Report Date
    February 28, 2025
    Manufacturer
    LENOX-MACLAREN SURGICAL CORP.
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SPOON PART OF THE CURETTE BROKEN INSIDE THE PATIENT. BOTH PARTS WERE ACCOUNTED FOR AND REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221599 CURETTE CURETTE, SURGICAL, GENERAL USE FZS LENOX-MACLAREN SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown