MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for LS PRO SYSTEMS LOW LEVEL LIGHT THERAPY LSG 264 LSG GENERAL PAD manufactured by Ls Pro Systems.
[114537197]
Product overheated and burnt patient during use. The low level laser therapy was advertised as fda approved during trade show. It has come to my attention under further investigation. The units were fda approved and have had 3 incidents of overheating. This has been the most significant. Name and strength: lsg 264, not sure anymore unk. Dose or amount: 2an; frequency: daily. Dates of use: (b)(6) 2018 to (b)(6) 2018. Diagnosis or reason for use: to heal patient's wounds. "is the product compounded: no. Is the product over-the-counter: no. " event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078463 |
| MDR Report Key | 7697760 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-07-13 |
| Date Added to Maude | 2018-07-18 |
| 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 |
| 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 | LS PRO SYSTEMS LOW LEVEL LIGHT THERAPY |
| Generic Name | LAMP, INFRARED, THERAPEUTIC HEATING |
| Product Code | ILY |
| Date Received | 2018-07-17 |
| Model Number | LSG 264 |
| Catalog Number | LSG GENERAL PAD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LS PRO SYSTEMS |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-17 |