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

Model Number 120

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 03/05/2014

Event Type  Injury  

Manufacturer Narrative

Not returned to anodyne therapy llc.

Event Description

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.

• Brand Name: ANODYNE THERAPY
• Type of Device: INFRARED DEVICE
• Manufacturer (Section D): ANODYNE THERAPY LLC; 14105 mccormick drive; tampa FL 33626
• Manufacturer (Section G): ANODYNE THERAPY LLC; 14105 mccormick drive; tampa FL 33626
• Manufacturer Contact: candace turtzo ; 14105 mccormick drive; tampa, FL 33626 ; 8133424432
• MDR Report Key: 5811671
• MDR Text Key: 50078260
• Report Number: 1055581-2016-00001
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 120
• Device Catalogue Number: 498003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR