MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-05-26 for MEDICAL MAGGOTS WITH LEFLAP DRESSING NA manufactured by Monarch Labs, Llc..
[1199068]
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.
Patient Sequence No: 1, Text Type: D, B5
[8457982]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005735989-2009-00018 |
| MDR Report Key | 1394596 |
| Report Source | 05 |
| Date Received | 2009-05-26 |
| Date of Report | 2009-04-27 |
| Date of Event | 2009-04-13 |
| Date Mfgr Received | 2009-04-27 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2009-06-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 17875 SKY PARK CIRCLE, SUITE K |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9496793000 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICAL MAGGOTS WITH LEFLAP DRESSING |
| Product Code | NQK |
| Date Received | 2009-05-26 |
| Catalog Number | NA |
| Lot Number | MM-090406/CCII-090 |
| ID Number | USED W/CCII-090101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONARCH LABS, LLC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-05-26 |