BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 10876107 · Received November 20, 2020

    Report

    Report Number
    1423395-2020-00032
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    September 21, 2020
    Report Date
    November 20, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OKV
    UDI-DI
    10193489224696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, WHILE PREPPING A PATIENT FOR A HYSTEROSCOPY DILATION AND CURETTAGE (D/C) AFTER PREPPING THE VAGINA WITH A BETADINE SPONGE STICK, THE REGISTERED NURSE (RN) "PULLED IT OUT AND THE SPONGE HAD DETACHED AND REMAINED IN THE VAGINA." THE REPORTER STATES, "THE SURGEON HAD TO REMOVE THE SPONGE PORTION OF IT PRIOR TO THE START OF THE CASE. THERE WAS NO REPORT OF SERIOUS INJURY. HOWEVER DUE TO MEDICAL INTERVENTION AND IN ABUNDANCE OF CAUTION THIS MEDWATCH IS BEING FILED. THERE ARE NO SAMPLES OR PHOTOS AVAILABLE FOR RETURN AND EVALUATION. INVESTIGATION SUMMARY READS AS FOLLOWS: UNFORTUNATELY, WITHOUT A SAMPLE OR PHOTO WE ARE UNABLE TO CONFIRM THE ISSUE AND DETERMINE A ROOT CAUSE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED; THE SPONGE HAD DETACHED FROM THE STICK AND REMAINED IN THE VAGINA AFTER PREPPING THE PATIENT FOR SURGERY. THE SURGEON HAD TO REMOVE THE SPONGE PORTION OF THE SPONGE STICK PRIOR TO THE START OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338056 MEDLINE INDUSTRIES, INC. DBD-D&C OKV MEDLINE INDUSTRIES INC. DYNJ34432I 20DBT586 10193489224696

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention