BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COHEN UTERINE ELEVATOR WITH TIPS

    MDR report key: 4850349 · Received June 11, 2015

    Report

    Report Number
    MW5043109
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    JARIT
    Product Code
    LKF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ASSISTED TO RESTROOM AFTER SURGERY. THE TIP OF A UTERINE ELEVATOR FELL OUT OF HER VAGINA AND INTO TOILET. NO INJURY TO PT. THERE IS NO LOT NUMBER BECAUSE IT IS AN INSTRUMENT AND NOT SUPPLY. IT WAS CLEANED AND PUT BACK INTO CIRCULATION BY SURGERY STAFF. THIS TIP SCREWS ONTO THE END OF THE COHEN UTERINE ELEVATOR. PHYSICIAN NOTIFIED, PT NOTIFIED, SAFETY OFFICER, NURSE MGR, AND DIR OF NURSING AND SURGERY NOTIFIED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381052 COHEN UTERINE ELEVATOR WITH TIPS COHEN UTERINE ELEVATOR WITH TIPS LKF JARIT 505-230 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 06/12/1 Other