MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for REJUVENATOR UNIVERSAL#3 manufactured by Unknown.
[136610641]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083858 |
| MDR Report Key | 8320872 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-11-01 |
| Date Added to Maude | 2019-02-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REJUVENATOR |
| Generic Name | LAMP, INFRARED, THERAPEUTIC HEATING |
| Product Code | ILY |
| Date Received | 2019-02-07 |
| Model Number | UNIVERSAL#3 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-07 |