BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL MAGGOTS

    MDR report key: 9508086 · Received December 20, 2019

    Report

    Report Number
    3005735989-2019-00001
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    October 16, 2019
    Report Date
    December 20, 2019
    Manufacturer
    MONARCH LABS
    Product Code
    NQK
    PMA / PMN Number
    K033391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WITH PRE-EXISTING WOUND PAIN UNDERWENT MAGGOT THERAPY FOR WOUND DEBRIDEMENT; DEVELOPED WOUND PAIN DURING MAGGOT THERAPY (AN ACCEPTED AND DOCUMENTED RISK) AND PRESENTED TO THE ER. ACCORDING TO THE REPORTING NURSE, THE PATIENT HAS DEMENTIA AND THE EXAMINING DOCTORS WERE NOT CONVINCED ABOUT THE SEVERITY OF HER PAIN. REPORTEDLY HER PAIN WAS TREATEC ONLY WITH ACETAMINOPHEN, AND WHEN THAT DID NOT CONTROL THE PAIN, SHE WAS ADMITTED TO HOSPITAL. I WAS CALLED AT 5:AM BY THE REPORTING NURSE AND ASKED IT WAS TOO EARLY (24 HOURS OF USE) TO REMOVE THE MAGGOTS IN ORDER TO RELIEVE THE PAIN. I RESPONDED THAT, WHENEVER ANALGESICS DO NOT CONTROL THE MAIN, THE MAGGOTS SHOULD BE REMOVED IN ORDER TO END THEIR STIMULATION OF THE NERVES IN THE WOUND, AND THEREBY TERMINATE THE PAIN. I NOTED THAT THIS IS DESCRIBED IN THE PACKAGE INSERT, AND THAT IT IS NEVER "TOO EARLY" TO REMOVE THE MAGGOTS, IF THE MEDICAL NEED SUGGESTS THAT THEY SHOULD BE REMOVED. I ALSO AGREED THAT ACETOMINOPHEN MAY HAVE BEEN TOO MEAGER AN ATTEMPT AT PAIN CONTROL, IN THIS CASE, BUT THAT THE THERAPIST SHOULD NOT WASTE TIME TRYING STRONGER PAIN MEDICATION AT THIS POINT BUT RATHER TERMINATE THE PAIN I,IMMEDIATELY BY REMOVING THE MAGGOTS. I ASKED THE THERAPIST TO CONTACT ME IF THIS DID NOT RELIEVE THE PROBLEM. I CALLED BACK SHORTLY THEREAFTER AND LEFT MESSAGE AND TEXT TO SUBMIT REPORT AND/OR CALL ME TO GE THE DETAILED INFORMATION AND FOLLOW-UP.

    Description of Event or Problem · 1

    PATIENT UNDERGOING MAGGOT THERAPY WAS HOSPITALIZED FOR WOUND PAIN. I WAS CALLED 5:AM LOCAL TIME BY NURSE ASKING IF IT IS OK TO REMOVE MAGGOTS EARLY (<48 HRS) FROM PATIENT HAVING INCREASED WOUND PAIN. PT WAS RECEIVING ONLY TYLENOL FOR PAIN, SHOWED UP TO THE ER AND WAS ADMITTED FOR PAIN CONTROL. I RESPONDED: YES, REMOVE THE MAGGOTS TO RESOLVE PAIN, AS DESCRIBED IN THE PACKAGE INSERT. I CALLED AND TEXTED LATER, ASKING THAT SHE COMPLETE AN ADVERSE EVENT REPORT AND/OR CALL ME BACK TO GATHER INFORMATION FOR OUR REPORT; BUT I HAVE NOT YET RECEIVED ANY FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294948 MEDICAL MAGGOTS MEDICINAL MAGGOTS, NQK MONARCH LABS MM-2019-10-13

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization