BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBETT POD

    MDR report key: 11938374 · Received June 3, 2021

    Report

    Report Number
    MW5101701
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 1, 2021
    Manufacturer
    TURBETT SURGICAL, INC.
    Product Code
    FRG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BREACH AT THE SEAM OF THE TURBETT POD (SURGICAL INSTRUMENT CONTAINMENT SYSTEM) WHICH RENDERS INSTRUMENTS CONTAMINATED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832012 TURBETT POD WRAP, STERILIZATION FRG TURBETT SURGICAL, INC. TS1500 100036

    Patients

    Seq Age Sex Outcome Treatment
    1