MAUDE Adverse Event Report: HOLLYWOG, LLC WITOUCH; OVER THE COUNTER TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR

Model Number	11.1510
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	09/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dhr review shows the device performed as intended when it was manufactured.During evaluation the device and device remote were found in poor condition.The device and device remote control were able to power on.The device treatment was able to function to specification, frequencies were to specification.The device labeling was reviewed and found to be suitable and adequate for the device to perform its intended use.The device performed to specification.
Event or Problem Description
Customer has spinal stenosis and has been wearing the device for two weeks.There were no problems until (b)(6) 2016.She was wearing the unit all day and it had turned itself off.Customer said she "got in the car to go somewhere and all of a sudden it let out a charge that tightened every muscle in my body and caused me to yell out loud." she had her remote control around her neck and was able to decrease the intensity.

• Brand Name: WITOUCH
• Common Device Name: OVER THE COUNTER TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR
• Manufacturer (Section D): HOLLYWOG, LLC; 2830 amnicola highway; chattanooga TN 37406 3605
• MDR Report Key: 6026815
• Report Number: 3008585473-2016-00620
• Device Sequence Number: 18850883
• Product Code: NUH
• UDI-Device Identifier: 00853096004014
• UDI-Public: 00853096004014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 11.1510
• Device Catalogue Number: 11.1510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Device Age: 10 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2016
• Initial Report FDA Received Date: 10/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 50 YR