BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 20662524 · Received November 12, 2024

    Report

    Report Number
    3011137372-2024-00176
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 21, 2024
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    POD
    PMA / PMN Number
    K220971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). FULL UDI IS NOT AVAILABLE AS THE LOT# WAS NOT PROVIDED BY THE CUSTOMER. NO DEVICE RETURNED. WARNING ON PAGE 2 OF IFU STATES "QUIKCLOT CONTROL + IS NOT ABSORBABLE AND MUST BE REMOVED FROM THE WOUND PRIOR TO WOUND CLOSURE". IN THE INTENDED USE STATES "DO NOT LEAVE QUIKCLOT CONTROL+ DRESSING IN PLACE FOR MORE THAN 48 HOURS". THIS EVENT WAS THE RESULT OF USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "4020 WAS PACKED IN THE LEG OF THE PATIENT DURING A FASCIOTOMY IN THE OR. THE LEG WAS LEFT OPEN AND THE PATIENT WAS TRANSFERRED TO THE ICU. THE FELLOW CLOSED THE FASCIOTOMY IN THE ICU LEAVING THE 4020 INSIDE THE PATIENTS LEG. THE PRODUCT WAS CORRECTLY DOCUMENTED ON THE PATIENT'S AVATAR IN THEIR CHART PER THE FACILITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058478 QC CONTROL+, 3" X 2 YD Z-FOLD, 10X TEMPORARY, INTERNAL USE HEMOS POD Z-MEDICA, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED