MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-07-21 for ANODYNE THERAPY 120 498003 manufactured by Anodyne Therapy Llc.
[50078260]
Not returned to anodyne therapy llc.
Patient Sequence No: 1, Text Type: N, H10
[50078261]
Patient is reported to have developed severe personal injuries following treatment with the anodyne therapy system that she purchased from anodyne therapy on 5/6/5002. No evidence has been provided to confirm these personal injuries occured or that the anodyne therapy system contributed to the event. The information provided in this event description has been reported by patient's attorney. We will provide any additional relevant information that may be received in this investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1055581-2016-00001 |
| MDR Report Key | 5811671 |
| Report Source | OTHER |
| Date Received | 2016-07-21 |
| Date of Report | 2016-05-23 |
| Date of Event | 2014-03-05 |
| Date Mfgr Received | 2016-05-23 |
| Device Manufacturer Date | 2002-05-04 |
| Date Added to Maude | 2016-07-21 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CANDACE TURTZO |
| Manufacturer Street | 14105 MCCORMICK DRIVE |
| Manufacturer City | TAMPA FL 33626 |
| Manufacturer Country | US |
| Manufacturer Postal | 33626 |
| Manufacturer Phone | 8133424432 |
| Manufacturer G1 | ANODYNE THERAPY LLC |
| Manufacturer Street | 14105 MCCORMICK DRIVE |
| Manufacturer City | TAMPA FL 33626 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33626 |
| 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 | 2016-07-21 |
| Model Number | 120 |
| Catalog Number | 498003 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANODYNE THERAPY LLC |
| Manufacturer Address | 14105 MCCORMICK DRIVE TAMPA FL 33626 US 33626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-07-21 |