BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMLINE CURETTE

    MDR report key: 12008115 · Received June 15, 2021

    Report

    Report Number
    MW5101905
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 11, 2021
    Manufacturer
    TSI / TEDAN SURGICAL INNOVATIONS, INC.
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    TIP OF CURETTE BROKE OFF DURING USE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894049 TRIMLINE CURETTE CURETTE, SURGICAL, GENERAL USE FZS TSI / TEDAN SURGICAL INNOVATIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention