BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 10705480 · Received October 20, 2020

    Report

    Report Number
    3004519921-2020-00001
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    June 11, 2020
    Report Date
    October 20, 2020
    Manufacturer
    TRI-STATE DE MEXICO
    Product Code
    HFX
    UDI-DI
    10889942395415
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT ORIGINALLY SUBMITTED IN ERROR UNDER INCORRECT MANUFACTURING NUMBER (1824619-2020-00010). IT WAS REPORTED THAT THE CIRCUMCISION DEVICE WOULD NOT SCREW DOWN FAR ENOUGH DURING A CIRCUMCISION TO PREVENT THE PENIS FROM BLEEDING. THE DOCTOR STATED THAT HE SCREWED THE DEVICE DOWN AS TIGHT AS HE COULD, AND WHEN HE REMOVED THE DEVICE THE PENIS BLED. PRESSURE HAD TO BE APPLIED AND THE DOCTOR PUT A SURGICAL ABSORBABLE HEMOSTAT ON THE AREA TO CONTROL THE BLEEDING. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AND THE BABY WAS REPORTEDLY DOING FINE. UN-USED SAMPLES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION IT WAS DETERMINED THAT THE FACILITY WAS DISASSEMBLING AND STERILIZING THE DEVICE IN AN AUTOCLAVE PRIOR TO USE AGAINST MANUFACTURER INSTRUCTIONS. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CIRCUMCISION DEVICE WOULD NOT SCREW DOWN FAR ENOUGH DURING A CIRCUMCISION TO PREVENT THE PENIS FROM BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167616 MEDLINE INDUSTRIES, INC. GOMCO CLAMP 1.45CM HFX TRI-STATE DE MEXICO DYND04197 2020050490 10889942395415

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA Required Intervention