MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-09 for CLASS IV LASER TREATMENT THE LCT-1000 manufactured by Litecure.
[67370323]
I have lower back problem and went to physical therapy. The therapist had laser therapy using lct 1000 by litecure company on my lower back. I think, i had laser treatment about 5 minutes. During treatment, i experienced discomfort in my heart, and my heart started pounding. After treatment, i had dizziness, headache and nausea, and my heart kept pounding hard. I felt very, very tired and did not want to do anything, just lied in bed. Treated area felt very warm, and had burning and stinging pain. My lower back pain increased after treatment, i had difficulty in walking and even sitting. Treated area (skin) looks brownish. After a day, my pain is still severe. Burning and stinging pain in treated area. Hard to walk and sit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067844 |
| MDR Report Key | 6325814 |
| Date Received | 2017-02-09 |
| Date of Report | 2017-02-09 |
| Date of Event | 2017-02-08 |
| Date Added to Maude | 2017-02-13 |
| 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 | CLASS IV LASER TREATMENT THE LCT-1000 |
| Generic Name | LAMP INFRARED, THERAPEUTIC HEATING |
| Product Code | ILY |
| Date Received | 2017-02-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LITECURE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2017-02-09 |