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

Model Number 11.1510

Device Problem Output Problem (3005)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 09/07/2016

Event Type  malfunction  

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 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
• Type of Device: OVER THE COUNTER TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR
• Manufacturer (Section D): HOLLYWOG, LLC; 2830 amnicola highway; chattanooga TN 37406 3605
• Manufacturer Contact: michael treas ; 2830 amnicola highway; chattanooga, TN 37406-3605 ; 4233057778
• MDR Report Key: 6026815
• MDR Text Key: 57332605
• Report Number: 3008585473-2016-00620
• Device Sequence Number: 1
• Product Code: NUH
• UDI-Device Identifier: 00853096004014
• UDI-Public: 00853096004014
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 50 YR