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U.S. Department of Health and Human Services

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

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HOLLYWOG, LLC WITOUCH OVER THE COUNTER TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR Back to Search Results
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.
 
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Brand NameWITOUCH
Type of DeviceOVER 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 Key6026815
MDR Text Key57332605
Report Number3008585473-2016-00620
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120500
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
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 Received10/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11.1510
Device Catalogue Number11.1510
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age10 MO
Event Location No Information
Date Manufacturer Received09/13/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/13/2016 Patient Sequence Number: 1
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