• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6704027
MDR Text Key79727942
Report Number3008585473-2017-00010
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 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number11.1510
Device Catalogue Number11.1510
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age22 MO
Event Location No Information
Date Manufacturer Received05/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/11/2017 Patient Sequence Number: 1
-
-