MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-10 for LIGHTFORCE LTS-1500P manufactured by Litecure Llc.
[91842294]
Litecure representative noted that neither the doctor nor the four staff members that were trained after initial sale of the laser were still at the practice. And, there was no communication from the practice to indicate that personnel had changed. The user manual provides multiple warnings emphasizing that no untrained personnel are to use the laser and use in the presence of poor circulation is not recommended, which is also shown as a warning statement on the product label. There are also warning and caution symbols on the product label indicating the need to consult the instructions for use prior to operating the device and to exhibit caution when using the device. Warnings from labeling: "use carefully. May cause serious burns. Do not use over sensitive skin area or in the presence of poor circulation. The unattended use of this device by children or incapacitated persons may be dangerous. " "never allow untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual. Do not leave key in device's key switch when not in use. Prevent unauthorized and/or unqualified use of the device. This will also prevent inadvertent laser emissions. " iso7010-m002 - follow instructions for use symbol. Iso7000-0434a - caution symbol. There was mention of a possible lawsuit being pursued by the patient against the practice, so it was in the manufacturer's best interest to submit a report since lawsuits typically do not stem from non-reportable injuries. However, this facet of the situation is likely the main contributor to the lack of information being provided to the manufacturer: -it is unclear whether a serious adverse event had occurred but it is policy to report injuries alleged by a medical professional. -it is also unclear who administered the treatment and what treatment technique was used when the injury occurred. -there has been no indication that a device malfunction contributed to the event and no intention of returning of the device to the manufacturer for evaluation has been communicated. Next steps include additional follow-up communication with the practice to attempt to receive the device for evaluation and provide user training, as needed, along with pursuing additional details regarding the patient, patient's existing conditions and medications, treatment, and injury. Litecure mdr procedures require at least 3 follow-up communication attempts prior to closing investigations as part of the complaint file and corrective action processes.
Patient Sequence No: 1, Text Type: N, H10
[91842295]
Initial report indicated a diabetic patient of an orthopedic and sports medicine clinic suffered a potential toe injury and a litecure therapy laser device may have caused or contributed to this injury. In follow up communications with the practice, the litecure representative retracted details regarding the location of the injury stating it was an assumption he made and that a body part was not specifically mentioned to him by the doctor, but that type of injury could happen in the foot area where diabetics typically suffer from neuropathy. The severity of the injury is unknown and the location has not been confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006268867-2017-00001 |
| MDR Report Key | 7019547 |
| Date Received | 2017-11-10 |
| Date of Report | 2017-11-10 |
| Date Mfgr Received | 2017-10-13 |
| Device Manufacturer Date | 2015-10-08 |
| Date Added to Maude | 2017-11-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ERIC ROCK |
| Manufacturer Street | 250 CORPORATE BLVD SUITE B |
| Manufacturer City | NEWARK DE 197023329 |
| Manufacturer Country | US |
| Manufacturer Postal | 197023329 |
| Manufacturer Phone | 3027090408 |
| Manufacturer G1 | LITECURE LLC |
| Manufacturer Street | 250 CORPORATE BLVD SUITE B |
| Manufacturer City | NEWARK DE 197023329 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197023329 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGHTFORCE |
| Generic Name | THERAPY LASER |
| Product Code | ILY |
| Date Received | 2017-11-10 |
| Model Number | LTS-1500P |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LITECURE LLC |
| Manufacturer Address | 250 CORPORATE BLVD SUITE B NEWARK DE 197023329 US 197023329 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-10 |