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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLYWOG, LLC WITOUCH PRO TRANSCUTANEOUS ELECTRICAL NERVE SIMULATOR

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HOLLYWOG, LLC WITOUCH PRO TRANSCUTANEOUS ELECTRICAL NERVE SIMULATOR Back to Search Results
Catalog Number 11.1500
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Skin Irritation (2076); Burn, Thermal (2530)
Event Date 02/16/2016
Event Type  Injury  
Manufacturer Narrative
This complaint was found on the internet during postmarket surveillance of anonymous customer reviews with limited information provided for an investigation. The certificates of compliance for the gel pads were reviewed by the qms management representative for a period of two years prior to the date of the annonymous customer review date shown on the internet. This review showed the gel pads were supplied to specification.
 
Event Description
These pads made my back break out and burn and sting. I will never order again, but i noticed they are not being made anymore. The original ones i got from sharper image did not have this effect non my back.
 
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Brand NameWITOUCH PRO
Type of DeviceTRANSCUTANEOUS ELECTRICAL NERVE SIMULATOR
Manufacturer (Section D)
HOLLYWOG, LLC
100 cherokee boulevard
suite 123
chattanooga TN 37405
Manufacturer Contact
michael treas
100 cherokee boulevard
suite 123
chattanooga, TN 37405
4233057777
MDR Report Key8816734
MDR Text Key151946755
Report Number3008585473-2019-00005
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
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 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number11.1500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/23/2019 Patient Sequence Number: 1
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