FDA Adverse Event
Injury
Summary report: N
ANODYNE THERAPY
MDR report key: 5811671
·
Received July 21, 2016
Report
- Report Number
- 1055581-2016-00001
- Event Type
- Injury
- Date Received
- July 21, 2016
- Date of Event
- March 5, 2014
- Report Date
- May 23, 2016
- Manufacturer
- ANODYNE THERAPY LLC
- Product Code
- ILY
- PMA / PMN Number
- K931261
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
NOT RETURNED TO ANODYNE THERAPY LLC.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 465066 | ANODYNE THERAPY | INFRARED DEVICE | ILY | ANODYNE THERAPY LLC | 120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization |