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Model Number LTS-1500P
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
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.
Event Description
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.
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Manufacturer (Section D)
250 corporate blvd
suite b
newark DE 19702 3329
Manufacturer (Section G)
250 corporate blvd
suite b
newark DE 19702 3329
Manufacturer Contact
eric rock
250 corporate blvd
suite b
newark, DE 19702-3329
MDR Report Key7019547
MDR Text Key91842294
Report Number3006268867-2017-00001
Device Sequence Number1
Product Code ILY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberLTS-1500P
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/13/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/08/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse