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	05/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dhr review shows the device performed as intended when it was manufactured.The tens device and handheld remote control were able to power on.The device output treatment frequencies were to specification, however, the waveform was not to specification.The device is will be evaluated by the design engineers for root cause of the waveform not performing to specification.The device labeling was reviewed and found to be suitable and adequate for the device to perform its intended use.
Event or Problem Description
The customer complained that when she pressed the power button on the remote control to start the treatment, the device gave her a "jolt" and then stopped working altogether.

• 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: 6704027
• Report Number: 3008585473-2017-00010
• Device Sequence Number: 1948227
• Product Code: NUH
• UDI-Device Identifier: 00853096004014
• UDI-Public: 00853096004014
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/22/2017
• Device Age: 22 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 07/11/2017
• 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