BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL MAGGOTS WITH LEFLAP DRESSING

    MDR report key: 1394598 · Received May 26, 2009

    Report

    Report Number
    3005735989-2009-00019
    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 THE CELLULITIS UNDER AND JUST PERIPHERAL TO THE HYDROCOLLOID PAD. NOTABLY DIFFERENT ABOUT THESE 2 PTS WAS THE BETADINE SCRUB (X3) OVER THIS AREA, 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 FORM THIS BATCH OF MEDICAL MAGGOTS SHOWED NO GROWTH, AND ALTHOUGH VALIDATION AND VERIFICATION OF LEFLAP STERILIZATION BY OUTSIDE AGENCY WAS FOUND TO MEET SPECIFICATIONS, WE CULTURED 3% OF ALL REMAINING DRESSINGS FROM THIS BATCH OURSELVES AND FOUND NO GROWTH. CONCLUSION: RESIDUAL BETADINE ON SKIN, COVERED BY THE HYDROCOLLOID DRESSING, WAS THE LIKELY CAUSE OF THE CELLULITIS. POVIDONE IODINE MSDS AND PACKAGE INSERTS WARN AGAINST ALLOWING RESIDUAL TO REMAIN UNDER OCCLUSIVE DRESSINGS. 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 ON 4/27/09 THAT WHEN SHE REMOVED MAGGOT DRESSINGS IN 2009, 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), AND THE PT DID WELL, WITH COMPLETE RESOLUTION OF THE CELLULITIS. 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. FOR BOTH PTS, 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 91 YR Required Intervention PRIOR TO APPLICATION OF MAGGOT DRESSING| PRIOR MAGGOT THERAPY| POVIDONE IODINE SCRUB OF SKIN X 3 IMMEDIATELY| TOPICAL ANTIBIOTIC OINTMENT FOR AT LEAST 1 WEEK