MAUDE Adverse Event Report: UNKNOWN REJUVENATOR; LAMP, INFRARED, THERAPEUTIC HEATING

Model Number UNIVERSAL#3

Device Problems Break (1069); Defective Device (2588); Noise, Audible (3273)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/01/2018

Event Type  malfunction  

Event Description

Rejuvenator light device led and infrared.They are saying on (b)(6) that this is a grade 2 medical device.The (b)(6) group is closed.Also they are recommending for use on the eyes.Elsewhere doctors are saying that looking at infrared is bad for the retina.Next problem is that the light keeps blinking and buzzing.The owner told me just to get a new cord.I did so and same problem with the new cord.It¿s supposed to have a one year warranty, but she keeps saying it¿s my fault that i am breaking the cords.Now i have it at repair shop.They are saying faulty soldering on the switch.A lot of people are having this issue and posting it on (b)(6).The owner just deletes the posts.This product seems faulty, dangerous, and is being prescribed wrong.(b)(4).

• Brand Name: REJUVENATOR
• Type of Device: LAMP, INFRARED, THERAPEUTIC HEATING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8320872
• MDR Text Key: 136610641
• Report Number: MW5083858
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNIVERSAL#3
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 52