BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT: CIRCUMCISION 20/CS

    MDR report key: 25201155 · Received May 18, 2026

    Report

    Report Number
    1030451-2026-00021
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 18, 2026
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    OHG
    UDI-DI
    20809160006020
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT 5 OF 9. 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 GAUZE 4 X 4 8 PLY COMPONENT, CG-1044-8-4 (LOT 2507JK228A). THE LOT MANUFACTURED IN THE COMPLAINT CONVENIENCE KIT LOT WAS SOURCED FROM SUPPLIER, (B)(4). 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

    THE CUSTOMER REPORTED ISSUES WITH THE 4 X 4 COTTON GAUZE CONTAINED WITHIN CIRCUMCISION CONVENIENCE KIT MANUFACTURED BY MEDICAL ACTION INDUSTRIES. DURING APPROXIMATELY NINE CIRCUMCISION CASES, SMALL COTTON FIBERS WERE OBSERVED SHEDDING FROM THE GAUZE, REQUIRING ADDITIONAL TIME TO REMOVE THEM TO PREVENT RETENTION AT THE SURGICAL SITE. NO PATIENT INJURIES WERE REPORTED AS A RESULT OF INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535672 KIT: CIRCUMCISION 20/CS KIT: CIRCUMCISION 20/CS OHG MEDICAL ACTION INDUSTRIES 56779 340235 20809160006020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other