MAUDE Adverse Event Report: ANODYNE THERAPY, LLC ANODYNE THERAPY; INFRARED DEVICE

Model Number 480

Device Problem Insufficient Information (3190)

Patient Problem Cellulitis (1768)

Event Date 05/07/2015

Event Type  Injury  

Event Description

Pt advises that she received a topical burn following treatment with anodyne therapy administered by a healthcare professional.This was the 11th treatment received, with no prior problems.Pt reports she went to the er for treatment 2 days following this anodyne treatment.Pt provided the er notes which confirm absence of treatment consistent with a topical burn, ie no topical treatment and no wound covering.Er notes do not mention a thermal injury, rather that pt was treated for cellulites with antibiotics and pain medication.Pt also provided visual evidence that does not show a topical burn, rather multiple skin red marks covering both legs in places where anodyne pads were not placed based upon both clinical protocols and soap notes from the treating facility / physician.

Manufacturer Narrative

Anodyne therapy contacted treating facility to discuss the reports made by the pt.Facility provided soap notes and treatment protocols which dod not support a topical burn or any other injury.Facility was requested to identify the anodyne system used during treatment, and return it anodyne for eval, but has failed to do so.Follow up calls were made to schedule add'l training for facility users as is our normal practice.All calls were not returned, and facility stated we were not to contact staff members.In summation, no evidence has been provided to confirm a topical burn has occurred, or that anodyne therapy contributed to the reported event.We do not anticipate receiving any further info to continue an investigation, however if we do, we will report as appropriate.Pt reports she is currently 90-95% healed.

• Brand Name: ANODYNE THERAPY
• Type of Device: INFRARED DEVICE
• Manufacturer (Section D): ANODYNE THERAPY, LLC; 14105 mccormick dr; tampa FL 33636
• Manufacturer Contact: candace turtzo ; 14104 mccormick dr; tampa, FL 33626 ; 8133424432
• MDR Report Key: 4827570
• MDR Text Key: 20720819
• Report Number: 1055581-2015-00001
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 480
• Device Catalogue Number: 498015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR