BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL MAGGOTS WITH LEFLAP DRESSING

    MDR report key: 1394596 · Received May 26, 2009

    Report

    Report Number
    3005735989-2009-00018
    Event Type
    Injury
    Date Received
    May 26, 2009
    Date of Event
    April 13, 2009
    Report Date
    April 27, 2009
    Manufacturer
    MONARCH LABS, LLC.
    Product Code
    NQK
    PMA / PMN Number
    K033391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF CELLULITIS HAS NOT BEEN REPORTED PREVIOUSLY, AND YET NOW THE FIRST TWO PTS OF THIS THERAPIST DEVELOPED CELLULITIS UNDER AND BEYOND THE HYDROCOLLOID DRESSING. NOTABLY DIFFERENT ABOUT THESE 2 PTS WAS THE BETADINE SCRUB X3 OVER THE AFFECTED SKIN IMMEDIATELY BEFORE COVERING THE SKIN WITH THE HYDROCOLLOID DRESSING. SEVERE CELLULITIS HAS BEEN DESCRIBED AS A RESULT OF BETADINE UNDER OCCLUSIVE DRESSINGS, AND LIKELY THIS WAS THE CAUSE IN THIS CASE. NO OTHER USERS OF THIS BATCH OF MAGGOTS (BASED ON ACTIVE INVESTIGATION OF ALL USERS) OR THE ACCOMPANYING LEFLAP DRESSING (BASED ON LACK OF PRIOR REPORTS) EXPERIENCED ANY PROBLEM. MICROBIAL CULTURES FROM THIS BATCH OF MEDICAL MAGGOTS SHOWED NO GROWTH, AND ALTHOUGH VALIDATION AND VERIFICATION OF LEFLAP STERILIZATION BY OUTSIDE AGENCY (LSO) WAS FOUND TO MEET SPECIFICATIONS, WE CULTURED 3% OF ALL REMAINING DRESSINGS FROM THIS BATCH OURSELVES; WE FOUND NO MICROBIAL CONTAMINATION. CONCLUSION: RESIDUAL BETADINE ON SKIN, COVERED BY THE HYDROCOLLOID DRESSING, WAS THE LIKELY CAUSE OF THE CELLULITIS. BETADINE MSDS AND PACKAGE INSERTS WARN AGAINST ALLOWING RESIDUAL TO REMAIN UNDER OCCLUSIVE DRESSINGS. THE INFECTION IN THIS CASE IS CONSISTENT WITH KNOWN AND LABELED WARNINGS THAT PSEUDOMONAS IS NOT KILLED BY, AND MAY PROPAGATE DURING MAGGOT THERAPY. COLONIZATION MAY HAVE BEEN ENHANCED BY THE MANY PRIOR ABX TREATMENTS FOR RECURRENT CELLULITIS, THE TOPICAL ANTIBIOTIC ABX PRIOR TO INCIDENT, AND MAYBE EVEN THE APPLICATION OF BETADINE ITSELF FROM THE MULTI-DOSE BOTTLE (THE BOTTLE NO LONGER AVAILABLE FOR TESTING). INTERVENTION/PREVENTIVE ACTION: NOTICE WILL BE SENT TO ALL CURRENT USERS; WARNINGS AGAINST BETADINE PREP BEFORE MAGGOT THERAPY WILL BE INCLUDED IN FUTURE PRODUCT LABELING FOR MEDICAL MAGGOTS AND LEFLAP MAGGOT DRESSINGS.

    Description of Event or Problem · 1

    THE PT'S DOCTOR REPORTED IN 2009 THAT WHEN SHE REMOVED MAGGOT DRESSINGS TWO WEEKS PRIOR, SHE OBSERVED CELLULITIS (INFLAMMATION) OF THE SKIN SURROUNDING THE WOUND AND EXTENDING FROM THE WOUND MARGIN PERIPHERALLY BEYOND THE DRESSING AREA. SHE TREATED THIS WITH AUGMENTIN (AS SHE USUALLY DID FOR RECURRENT CELLULITIS IN THIS PT), BUT THIS TIME THE CELLULITIS DID NOT RESOLVE. CULTURE A WEEK PRIOR TO ORIGINAL DATE: PSEUDOMONAS AERUGENOSA, SO THE PT WAS TREATED WITH LEVOFLOXACIN. SHE DID NOT RESPOND, SO WAS HOSPITALIZED ON ORIGINAL DATE, TREATED WITH ZOSYN, DID WELL, AND WAS DISCHARGED WITHOUT RESIDUAL SEQUELAE. IT IS OF NOTE THAT THIS PT, ALONG WITH ANOTHER PT TREATED THE SAME DAY BY THE SAME DOCTOR, BOTH HAVE RECURRENT CELLULITIS, AND THEY BOTH DEVELOPED CELLULITIS WITH MAGGOT THERAPY. ANTIBIOTIC OINTMENT HAD BEEN USED TOPICALLY UP UNTIL MAGGOT DEBRIDEMENT, AND THE AREA WAS SCRUBBED WITH 10% POVIDONE IODINE (FROM A MULTI-DOSE BOTTLE) ON GAUZE PADS 3 TIMES, IMMEDIATELY BEFORE APPLYING THE MAGGOTS AND HYDROCOLLOID MAGGOT DRESSING OVER THE SCRUBBED SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL MAGGOTS WITH LEFLAP DRESSING NQK MONARCH LABS, LLC. MM-090406/CCII-090

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization PRIOR MAGGOT THERAPY,| PRIOR TO APPLICATION OF MAGGOT DRESSING| TOPICAL ANTIBIOTIC OINTMENT FOR AT LEAST 1 WK| POVIDONE IODINE SCRUB OF SKIN X 3 IMMEDIATELY