MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-01 for LITECURE LCT-1000 manufactured by Litecure.
[66475148]
Therapeutic laser cable at the connector where the cord attaches to the unit caught fire and melted due to a "short. " pt treatment ceased during the occurrence. No pt injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067628 |
| MDR Report Key | 6300004 |
| Date Received | 2017-02-01 |
| Date of Report | 2017-02-01 |
| Date of Event | 2017-01-25 |
| Date Added to Maude | 2017-02-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | LITECURE |
| Generic Name | THERAPEUTIC LASER |
| Product Code | ILY |
| Date Received | 2017-02-01 |
| Returned To Mfg | 2017-02-01 |
| Model Number | LCT-1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LITECURE |
| Manufacturer Address | NEWARK DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-01 |