MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-25 for ANODYNE THERAPY 480 498031 manufactured by Anodyne Therapy, Llc.
[4146181]
Treating facility reports a patient developed a burn with blisters approximately 1/2" x 1/2" and a reddened area 5cm x 2cm on the calf following an anodyne therapy treatment. Reported patient injury has completely healed.
Patient Sequence No: 1, Text Type: D, B5
[11330719]
The system involved in this complaint was returned for evaluation after patient reportedly developed a 2nd degree burn with blisters approximately 1/2 x 1/2" and a reddened area approximately 5cm x 2cm on the le calf following treatment with an anodyne therapy professional system. Patient self administered silvadene, and did receive medical intervention of a topical antibiotic. Reported treatment time and intensity was within the guidelines provided to the user in the ifu manual. Evaluation identified a broken wire in one therapy pad, and a bad connection in one jack, neither of which would be expected to cause high temperatures. Additionally, during simulated use, the therapy pad temperatures were found to be well within levels that would not be expected to cause a burn. The facility reported that they used this same anodyne unit on various other patients around the same time as the reported injury without incident. Accordingly, anodyne is not able to confirm that this anodyne unit caused the reported injury. The number of incidents of this type remain within the expected rate for this product based upon the number of incidents reported and the number of units in distribution. Company continues to monitor and trend events of this type.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1055581-2013-00004 |
| MDR Report Key | 3503984 |
| Report Source | 05 |
| Date Received | 2013-11-25 |
| Date of Report | 2013-10-30 |
| Date of Event | 2013-10-18 |
| Date Mfgr Received | 2013-10-23 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2013-12-09 |
| 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 | 14105 MCORMICK 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 LAMP |
| Product Code | ILY |
| Date Received | 2013-11-25 |
| Returned To Mfg | 2013-11-08 |
| Model Number | 480 |
| Catalog Number | 498031 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANODYNE THERAPY, LLC |
| Manufacturer Address | TAMPA FL 33626 US 33626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-25 |