BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOUND KIT

    MDR report key: 24616842 · Received March 17, 2026

    Report

    Report Number
    1030451-2026-00003
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 18, 2026
    Report Date
    April 22, 2026
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    OVN
    UDI-DI
    20809160264093
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF THE CONVENIENCE KIT CONTAINING THE COMPLAINT COMPONENT, (B)(4) LOTS 2518R0643G AND 2534R0634P PURCHASED FROM SPECIFICATION DEVELOPER, GLOBAL INSTRUMENTS INC. (FDA REGISTRATION 1057200). <BR /> THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). <BR /> 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

    ON (B)(6) 2026, THE CUSTOMER REPORTED A HEMOSTAT BROKE AFTER CHEST TUBE WAS REMOVED. THE HEMOSTAT WAS BEING USED TO CLAMP CHEST TUBE FOR REMOVAL. NO PATIENT INJURY, TREATMENT, OR DELAYS OCCURRED. THE BREAK HAPPENED AFTER BEDSIDE CHEST TUBE REMOVAL, NOT DURING AN EMERGENCY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682003 WOUND KIT WOUND KIT OVN MEDICAL ACTION INDUSTRIES 79350 339269 20809160264093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown