MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-20 for LIGHTFORCE LTC-1500 manufactured by Litecure, Llc.
[139373520]
No product malfunction suspected. Device being returned for evaluation to confirm. Supplemental report will be issued when evaluation completed.
Patient Sequence No: 1, Text Type: N, H10
[139373521]
Patient developed blister on foot that may have been contributed to by the subject device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006268867-2019-00002 |
| MDR Report Key | 8437489 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-04 |
| Date of Event | 2018-12-14 |
| Device Manufacturer Date | 2018-03-28 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Manufacturer Contact | ERIC ROCK |
| Manufacturer Street | 101 LUKENS DRIVE SUITE A |
| Manufacturer City | NEW CASTLE DE 197202791 |
| Manufacturer Country | US |
| Manufacturer Postal | 197202791 |
| Manufacturer Phone | 3027090408 |
| Manufacturer G1 | LITECURE, LLC |
| Manufacturer Street | 101 LUKENS DRIVE SUITE A |
| Manufacturer City | NEW CASTLE DE 197202791 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197202791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTFORCE |
| Generic Name | THERAPY LASER |
| Product Code | ILY |
| Date Received | 2019-03-20 |
| Model Number | LTC-1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LITECURE, LLC |
| Manufacturer Address | 101 LUKENS DRIVE SUITE A NEW CASTLE DE 197202791 US 197202791 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-20 |