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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLYWOG, LLC WITOUCH STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

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HOLLYWOG, LLC WITOUCH STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
Model Number 11.1510
Device Problem Insufficient Information (3190)
Patient Problem Rash (2033)
Event Date 11/30/2015
Event Type  Injury  
Manufacturer Narrative
A pre-paid postage package has been provided to the complainant to return the device for evaluation. After receipt of the pre-paid return package, the complainant decided not to return the device. The qms representative reviewed the assembly process including the device history record and no abnormalities were found.
 
Event Description
I bought the product and used it with the original gel-pads with no problems. When the original gel-pads were used up, i purchased replacement gel-pads online. Approximately four months ago when i began using the replacement gel-pads, i noticed a rash beginning in the area of my lower back where the product and replacement gel-pads were used. Over time the rash began spreading across my back and has now spread up to my neck, and spread down to the butt area. My physician diagnosed the rash to be staph infection by comparing the rash to photos of rashes in a book. I have never had staph infection before in my life. Four days ago, my physician prescribed antibiotics for me to take.
 
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Brand NameWITOUCH
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
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 Key5549382
MDR Text Key41939622
Report Number3008585473-2016-00611
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 03/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2016
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? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/23/2015
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: 04/05/2016 Patient Sequence Number: 1
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