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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLYWOG, LLC WITOUCH PRO TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR FOR PAIN RELIEF

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HOLLYWOG, LLC WITOUCH PRO TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR FOR PAIN RELIEF Back to Search Results
Model Number 11.1500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730)
Event Date 07/09/2018
Event Type  Injury  
Manufacturer Narrative
The pt. (consumer) indicated he has atrial fibrillation from a preexisting condition. The warnings! section of the instructions for use states: do not use this device if you are susceptible to rhythm disturbances to the heart unless under the direction of your physician. The pt. Stated he purchased the device on the internet without obtaining his physician's advice. He agreed not to continue using the device until he obtains advice from his physician. The pt. Stated he has used other manufacturers tens devices which he obtained through his physician at the (b)(6). The report was not a problem with the device, therefore, the device was not returned for evaluation. The dhr was reviewed which showed the device performed to specification when it was manufactured. There are no similar reports of atrial fibrilation from use of the device. The conclusion is this is an isolated event related to a pt. Preexisting condition and the pt. Did not read the warnings! section of the instructions for use: do not use this device if you are susceptible to rhythm disturbances to the heart unless under the direction of your physician.
 
Event Description
I purchased the device on (b)(6) and i experienced issues with my afib shortly after the first use of the device. I contacted my primary care physician at the (b)(6) to see if i can continue using the device. I will stop using the device until my doctor tells me if i can continue using the device.
 
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Brand NameWITOUCH PRO
Type of DeviceTRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR FOR PAIN RELIEF
Manufacturer (Section D)
HOLLYWOG, LLC
2830 amnicola highway
chattanooga TN 37406 3605
Manufacturer Contact
michael treas
2830 amnicola highway
chattanooga, TN 37406-3605
4233057777
MDR Report Key7675654
MDR Text Key113620107
Report Number3008585473-2018-00106
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171599
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number11.1500
Device Catalogue Number11.1500
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Device Age8 MO
Event Location Home
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/10/2018 Patient Sequence Number: 1
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