MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-09-23 for ANODYNE THERAPY 480 498012 manufactured by Anodyne Therapy, Llc.
[2234234]
Customer reported that the bar graph display did not go to the maximum setting. We requested that the unit be returned for eval, and a voltage regulator was found to be defective. There was no adverse event reported.
Patient Sequence No: 1, Text Type: D, B5
[9431095]
The system involved in this complaint was returned for eval and a voltage regulator failure was detected. No adverse event was reported, however, this type of malfunction could potentially cause an adverse event. 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 | 1055581-2011-00004 |
| MDR Report Key | 2273606 |
| Report Source | 04 |
| Date Received | 2011-09-23 |
| Date of Report | 2011-09-20 |
| Date of Event | 2011-08-22 |
| Date Mfgr Received | 2011-08-22 |
| Device Manufacturer Date | 2008-09-01 |
| Date Added to Maude | 2012-06-27 |
| 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 | 13570 WRIGHT CIRCLE |
| 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 | 2011-09-23 |
| Returned To Mfg | 2011-08-24 |
| Model Number | 480 |
| Catalog Number | 498012 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 | 2011-09-23 |