MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-06-03 for ANODYNE THERAPY 480 498015 manufactured by Anodyne Therapy, Llc.
[20720819]
Pt advises that she received a topical burn following treatment with anodyne therapy administered by a healthcare professional. This was the 11th treatment received, with no prior problems. Pt reports she went to the er for treatment 2 days following this anodyne treatment. Pt provided the er notes which confirm absence of treatment consistent with a topical burn, ie no topical treatment and no wound covering. Er notes do not mention a thermal injury, rather that pt was treated for cellulites with antibiotics and pain medication. Pt also provided visual evidence that does not show a topical burn, rather multiple skin red marks covering both legs in places where anodyne pads were not placed based upon both clinical protocols and soap notes from the treating facility / physician.
Patient Sequence No: 1, Text Type: D, B5
[21077065]
Anodyne therapy contacted treating facility to discuss the reports made by the pt. Facility provided soap notes and treatment protocols which dod not support a topical burn or any other injury. Facility was requested to identify the anodyne system used during treatment, and return it anodyne for eval, but has failed to do so. Follow up calls were made to schedule add'l training for facility users as is our normal practice. All calls were not returned, and facility stated we were not to contact staff members. In summation, no evidence has been provided to confirm a topical burn has occurred, or that anodyne therapy contributed to the reported event. We do not anticipate receiving any further info to continue an investigation, however if we do, we will report as appropriate. Pt reports she is currently 90-95% healed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1055581-2015-00001 |
| MDR Report Key | 4827570 |
| Report Source | 04 |
| Date Received | 2015-06-03 |
| Date of Report | 2015-05-11 |
| Date of Event | 2015-05-07 |
| Date Mfgr Received | 2015-05-11 |
| Date Added to Maude | 2015-06-10 |
| 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 Contact | CANDACE TURTZO |
| Manufacturer Street | 14104 MCCORMICK DR |
| Manufacturer City | TAMPA FL 33626 |
| Manufacturer Country | US |
| Manufacturer Postal | 33626 |
| Manufacturer Phone | 8133424432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANODYNE THERAPY |
| Generic Name | INFRARED DEVICE |
| Product Code | ILY |
| Date Received | 2015-06-03 |
| Model Number | 480 |
| Catalog Number | 498015 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANODYNE THERAPY, LLC |
| Manufacturer Address | 14105 MCCORMICK DR TAMPA FL 33636 US 33636 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-06-03 |