BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX

    MDR report key: 22410604 · Received July 7, 2025

    Report

    Report Number
    3007305485-2025-00107
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 16, 2025
    Report Date
    July 7, 2025
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    FZQ
    UDI-DI
    20653405037016
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT WHEN IT IS NOT POSSIBLE TO MAINTAIN AT LEAST 5 MM DISTANCE FROM THE STAPLED SKIN TO UNDERLYING BONES, VESSELS, AND INTERNAL ORGANS, THE USE OF STAPLES FOR SKIN CLOSURE IS CONTRAINDICATED. PRIOR TO INSERTING STAPLE, CONFIRM STAPLE WILL BE POSITIONED FREE OF OTHER STAPLES OR OBSTRUCTIONS. FIRING A STAPLE OVER ANOTHER STAPLE MAY RESULT IN TISSUE COMPRESSION AND RISK OF COMPROMISED HEALING OR SCARRING. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE THAT 8735, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE DEVICE WAS BEING USED DURING A CLOSURE OF A LACERATION PROCEDURE ON APPROXIMATELY (B)(6) 2025 WHEN IT WAS REPORTED ¿STAPLE GUN JAMMED. THERE WAS NO PATIENT INJURY. JUST A SMALL DELAY IN THE PROCEDURE. GUN WAS DISPOSED OF.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿IT GOT STUCK IN HIS HEAD AND THE PROVIDER HAD TO PRY THE DEVICE OFF.". THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897718 REFLEX CLIP, REMOVABLE (SKIN) FZQ CONSOLIDATED MEDICAL EQUIPMENT COMPANY 202408014 20653405037016

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Unknown