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 05/06/2017

Event Type  Injury  

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 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
• 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: 6704027
• MDR Text Key: 79727942
• Report Number: 3008585473-2017-00010
• 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: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/22/2017
• Device Age: 22 MO
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability