MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-08-30 for ANODYNE THERAPY 480 498026 manufactured by Anodyne Therapy, Llc.
[2162651]
Purchasing department reported their unit was not working properly and requested to return it for eval. No adverse event was reported. Eval identified broken wires that caused one therapy pad of the unit to operate at higher than normal temperatures and this could cause an adverse event if it were to recur.
Patient Sequence No: 1, Text Type: D, B5
[9348709]
The unit has been returned to anodyne for eval. The unit was found to have broken wires that caused one therapy pad to operate at higher than normal temperatures. The number of malfunctions 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 these events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1055581-2011-00003 |
| MDR Report Key | 2251633 |
| Report Source | 06 |
| Date Received | 2011-08-30 |
| Date of Report | 2011-08-30 |
| Date of Event | 2011-08-04 |
| Date Mfgr Received | 2011-08-04 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2012-06-22 |
| 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 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 LAMP |
| Product Code | ILY |
| Date Received | 2011-08-30 |
| Returned To Mfg | 2011-08-05 |
| Model Number | 480 |
| Catalog Number | 498026 |
| 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 | 2011-08-30 |