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

Model Number	11.1500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Atrial Flutter (1730)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: WITOUCH PRO
• Common Device Name: TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR FOR PAIN RELIEF
• Manufacturer (Section D): HOLLYWOG, LLC; 2830 amnicola highway; chattanooga TN 37406 3605
• MDR Report Key: 7675654
• Report Number: 3008585473-2018-00106
• Device Sequence Number: 16305005
• Product Code: NUH
• UDI-Device Identifier: 00853096004021
• UDI-Public: 00853096004021
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K171599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 11.1500
• Device Catalogue Number: 11.1500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• Event Location: Home
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 78 YR
• Patient Weight: 104