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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LUMANOSITY, INC. TENDLIFE LAMP, INFRARED, THERAPEUTIC HEATING

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LUMANOSITY, INC. TENDLIFE LAMP, INFRARED, THERAPEUTIC HEATING Back to Search Results
Model Number 204
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/19/2021
Event Type  Injury  
Event Description
Tendlite adverse reaction description: shingles. I have a diagnosed inflamed spinal disk between l3 and l4 on the right. On (b)(6) 2020, i had an epidural steroid injection to relieve pressure on the nerve coming that comes out there, due to prolonged pain from my right hip down to my ankle. This abnormality was due to a sports injury in (b)(6) 2019. On approximately (b)(6) 2021 (not written down, but was around that time), i used tendlite to administer 3 1-minute treatments to my spine at a location that was as best as i could guess where l3 and l4 would be. (it's red light therapy, you shine a device that looks like a small flashlight. You place it on the surface of your skin at the affected area. ) i looked online first for information stating whether this would be a bad idea and didn't find anything. I would have preferred to have a repeat steroid injection at the end of (b)(6) 2020, but it has been delayed to some time after (b)(6) 2021 due to a change in insurance and wait time to get established with an in-network physician. On (b)(6) 2020, shingles rashes began appearing on the right side on my back and my hip. Though the shingles virus had to be in my system for it to appear, and i wouldn't have used the tendlite at that location if i didn't have a spinal injury (which likely contributed to the shingles, too), it does seem most likely that the tendlite agitated the shingles virus and started an episode. This is the first case of shingles i have had. I also used the tendlite to administer treatment to my left hip near where the it band is attached (which i've already completed in office physical therapy for, and continued exercises at home). It relieved the pain and did not cause any side effects. On (b)(6) 2021, shingles was diagnosed at a doctor's visit. Discussed that the injury and tendlite may have been the opportunities that caused the shingles virus to activate. Fda safety report id#: (b)(4).
 
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Brand NameTENDLIFE
Type of DeviceLAMP, INFRARED, THERAPEUTIC HEATING
Manufacturer (Section D)
LUMANOSITY, INC.
MDR Report Key11236516
MDR Text Key229592309
Report NumberMW5099028
Device Sequence Number1
Product Code ILY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number204
Device Catalogue NumberDON'T KNOW
Device Lot NumberDON'T KNOW
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/26/2021 Patient Sequence Number: 1
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