InjuryILY
ANODYNE THERAPY
Received Jul 21, 2016 · Event occurred Mar 5, 2014
Report 1055581-2016-00001 · MDR key 5811671
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
75 YR
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
NOT RETURNED TO ANODYNE THERAPY LLC.
Description of Event or Problem
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.