BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESHEX

    MDR report key: 24523699 · Received March 5, 2026

    Report

    Report Number
    3011981870-2026-00001
    Event Type
    Injury
    Date Received
    March 5, 2026
    Date of Event
    February 6, 2026
    Report Date
    March 3, 2026
    Manufacturer
    EXSURCO MEDICAL
    Product Code
    FZW
    UDI-DI
    00810006780192
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RECEIVED BY THE MANUFACTURER FOR REVIEW. NO ANOMALIES WERE IDENTIFIED AS A PART OF A REVIEW OF PRODUCTION RECORDS.

    Description of Event or Problem · 0

    DURING A PROCEDURE ON (B)(6) 2026, IT WAS REPORTED THAT DURING THE SKIN GRAFT MESHING UTILIZING A 3:1 CUTTING ROLLER THERE WERE MANY MISSED CUTS ALONG THE GRAFTS. DUE TO THE AMOUNT OF MISSED CUTS, ANOTHER PIECE OF SKIN HAD TO BE TAKEN FROM THE PATIENT. A PROCEDURE DELAY OF UNKNOWN LENGTH OCCURRED DUE TO RE-CUTTING HOLES MANUALLY AND RETRIEVING MORE SKIN. REPORTED ROLLER: X101866 MESHEX MSH CUTTING ROLLER C SN: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586972 MESHEX EXPANDER, SURGICAL, SKIN GRAFT FZW EXSURCO MEDICAL X101866 X-0000000000003 00810006780192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention