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..
[1199105]
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.
Patient Sequence No: 1, Text Type: D, B5
[8389184]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005735989-2009-00019 |
| MDR Report Key | 1394598 |
| 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. Required No Informationntervention | 2009-05-26 |