BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAMP,CIRCUMCISION,11MM,1.1CM

    MDR report key: 22496191 · Received July 14, 2025

    Report

    Report Number
    1417592-2025-00336
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 16, 2025
    Report Date
    August 27, 2025
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS INC
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "WHEN TIGHTENING THE NUT OF THE GOMCO DEVICE WHERE THE BELL AND THE BEVEL HOLE OF THE PLATE MEET, INSTEAD OF PRODUCING A CRUSH INJURY, WE ARE NOTICING THAT THE DEVICE IS ACTUALLY CUTTING THE SKIN AND CAUSING SKIN SEPARATION WITH BLEEDING ON THE UNDERSIDE OF THE GOMCO DEVICE". THE CUSTOMER REPORTED THE INCIDENT IS OCCURRING PRIOR TO THE USE OF A SCALPEL, AND THEY IDENTIFIED THE HOLE IN THE BASE PLATE HAS A "STRAIGHT EDGE TO IT INSTEAD OF THE SLIGHT SLANT TO IT". THE CUSTOMER REPORTED AFTER THE INCIDENT OCCURRED, THE USE OF "AVITENE" WAS REQUIRED TO CONTROL THE BLEEDING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, 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. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, "WHEN TIGHTENING THE NUT OF THE GOMCO DEVICE WHERE THE BELL AND THE BEVEL HOLE OF THE PLATE MEET, INSTEAD OF PRODUCING A CRUSH INJURY, WE ARE NOTICING THAT THE DEVICE IS ACTUALLY CUTTING THE SKIN AND CAUSING SKIN SEPARATION WITH BLEEDING ON THE UNDERSIDE OF THE GOMCO DEVICE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278986 CLAMP,CIRCUMCISION,11MM,1.1CM HFX ALLIED HEALTHCARE PRODUCTS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other