BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOH CUP

    MDR report key: 1252006 · Received November 21, 2008

    Report

    Report Number
    1216677-2008-00039
    Event Type
    Injury
    Date Received
    November 21, 2008
    Report Date
    November 21, 2008
    Product Code
    HEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    IN KEEPING WITH GOOD MEDICAL PRACTICE, THE PHYSICIAN HAS THE RESPONSIBILITY TO ENSURE ALL NON-IMPLANTABLE DEVICES ARE REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOH CUP COLPOTOMIZER SYSTEM HEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention