BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC CONTROL+, 3IN X 2YD, Z-FOLD, 10X

    MDR report key: 24412888 · Received February 23, 2026

    Report

    Report Number
    3004138549-2026-00001
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 29, 2026
    Report Date
    January 30, 2026
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    POD
    PMA / PMN Number
    K220971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO SAMPLE BEING RETURNED FOR EVALUATION. IFU INSTRUCTIONS ADAQUATELY ESTABLISH THE NEED TO REMOVE THE PRODUCT PRIOR TO WOUND CLOSURE. THIS EVENT WAS THE RESULT OF THE USER NOT FOLLOWING PRODUCT IFU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "I WAS INFORMED BY FACILITY THAT A Z-FOLD WAS RETAINED IN THE PATIENT BY THE PROVIDER AFTER CLOSURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473176 QC CONTROL+, 3IN X 2YD, Z-FOLD, 10X TEMPORARY, INTERNAL USE HEMOS POD Z-MEDICA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.