BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT TISSUE ELEVATOR

    MDR report key: 10384488 · Received August 7, 2020

    Report

    Report Number
    MW5095964
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 6, 2020
    Manufacturer
    INNOMED, INC.
    Product Code
    HTE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING SCHEDULED KNEE SURGERY. IN ONE OF THE EXTRA INSTRUMENT TRAYS THAT IS OCCASIONALLY USED, THERE WAS A SOFT TISSUE ELEVATOR NOTED TO BE BROKEN. INSTRUMENT WAS TAKEN OUT OF THE TRAY AND A NEW INSTRUMENT OBTAINED. DID NOT REACH THE PATIENT. NO PATIENT HARM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846840 SOFT TISSUE ELEVATOR ELEVATOR HTE INNOMED, INC. 3450 L#0817MT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention