BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAMP,CIRCUMCISION,13MM,1.3CM

    MDR report key: 22640173 · Received July 29, 2025

    Report

    Report Number
    1417592-2025-00360
    Event Type
    Injury
    Date Received
    July 29, 2025
    Report Date
    August 25, 2025
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS INC
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLAMP CUTS TOO DEEPLY INTO THE FORESKIN CAUSING EXCESSIVE BLEEDING AND REQUIRES SUTURING. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATE TO D3. AFTER FURTHER INVESTIGATION IT HAS BEEN DETERMINED THAT THIS IS AN ALLIED HEALTHCARE PRODUCTS INC PRODUCT. THE INITIAL REPORTED ISSUE IS NOT A MEDLINE INDUSTRIES, LP PRODUCT. A THIRD-PARTY NOTIFICATION WAS PERFORMED WITH ALLIED HEALTHCARE PRODUCTS INC. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CLAMP CUTS TOO DEEPLY INTO THE FORESKIN CAUSING EXCESSIVE BLEEDING AND REQUIRES SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2576813 CLAMP,CIRCUMCISION,13MM,1.3CM HFX ALLIED HEALTHCARE PRODUCTS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other