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 LTS-2500 manufactured by Litecure, Llc.
[139359892]
Device returned for evaluation and no quality issues found. Device safety functions and performance were within specifications. Reported injury caused by known risk inherent with device type and documented in labeling and risk management. Incident type will be further analyzed through post market surveillance process.
Patient Sequence No: 1, Text Type: N, H10
[139359893]
Patient experienced lesion on shoulder several days after treatment due to incorrect procedure by operator. The provided dose was greater than the recommended level leading to overexposure. Treatment technique did not follow ifu. Also, patient had reduced sensation due to existing condition that was not disclosed prior to treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006268867-2019-00001 |
| MDR Report Key | 8437526 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-03 |
| Date of Event | 2019-01-17 |
| Date Mfgr Received | 2019-02-21 |
| Device Manufacturer Date | 2018-04-18 |
| 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 |
| Returned To Mfg | 2019-02-21 |
| Model Number | LTS-2500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LITECURE, LLC |
| Manufacturer Address | 101 LUKENS DR SUITE A NEW CASTLE DE 197202791 US 197202791 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-20 |