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

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.

• Brand Name: WITOUCH
• Type of Device: STIMULATOR, 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 Key: 5549382
• MDR Text Key: 41939622
• Report Number: 3008585473-2016-00611
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• 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 Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11.1510
• Device Catalogue Number: 11.1510
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 61 YR
• Patient Weight: 100