BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT: CIRCUMCISION 20/CS

    MDR report key: 25145136 · Received May 11, 2026

    Report

    Report Number
    1030451-2026-00014
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 11, 2026
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    OHG
    UDI-DI
    20809160006020
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT 3 OF 5. THE PRODUCT INVOLVED IN THE EVENT IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF THE CIRCUMCISION CONVENIENCE KIT CONTAINING THE COMPLAINT STRAIGHT HEMOSTAT COMPONENT, R0598 (LOTS 2541R0598 & 2441R0598G). THE TWO LOTS MANUFACTURED IN THE COMPLAINT CONVENIENCE KIT LOT WERE SOURCED FROM TWO DIFFERENT SUPPLIERS, GLOBAL INSTRUMENTS INC. (FDA REGISTRATION 1057200) & TAMZON INSTRUMENTS, INC. (FDA REGISTRATION 1421530). THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    STRAIGHT HEMOSTAT BROKE DURING CIRCUMCISION PROCEDURE. THE HEMOSTAT INSTRUMENT FAILED TO HOLD THE SKIN, COMING LOOSE. NO PATIENT HARM RESULTED FROM INCIDENT. SITE REPORTED THE HEMOSTAT FAILED 4-5 TIMES DURING 19 TOTAL CIRCUMCISIONS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533571 KIT: CIRCUMCISION 20/CS KIT: CIRCUMCISION 20/CS OHG MEDICAL ACTION INDUSTRIES 56779 340235 20809160006020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown