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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 Rash (2033)
Event Date 06/01/2016
Event Type  Injury  
Manufacturer Narrative
The device evaluation of the output waveforms: stage 1, stage 2 and stage 3 (all stages) function as intended to design specification. Device performed and functioned to specification.
 
Event Description
On two separate occasions i experienced hives/welts predominately on the right side of my lower back, but wasn't a big issue. The first occasion was worse than the second with more hives/welts. I cleansed my skin with alcohol before each use. I intermittently felt a higher intensity output on the right side, it almost always seemed to occur after i powered it off and then on again, or a 2nd or 3rd use concurrently. I used my lithium batteries from the beginning and throughout the entire first month without any issues in the original unit i purchased. I refrained from using the product for about six days, and applied calamine lotion to help stop the itching. I can't find a picture i thought i took of the first rash. I included a picture of the second rash and the lithium batteries i used. I will follow up with another picture of my back since it is fine and all healed now.
 
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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 (Section G)
HOLLYWOG, LLC
2830 amnicola highway
chattanooga TN 37406 3605
Manufacturer Contact
michael treas
2830 amnicola highway
chattanooga, TN 37406-3605
4233057778
MDR Report Key5854562
MDR Text Key51402785
Report Number3008585473-2016-00614
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 08/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2016
Is this an Adverse Event Report? Yes
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 Manufacturer07/11/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location Home
Date Manufacturer Received06/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2015
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: 08/08/2016 Patient Sequence Number: 1
Treatment
WITOUCH
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