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

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.

• Brand Name: WITOUCH PRO
• Type of Device: TRANSCUTANEOUS 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 Key: 8816734
• MDR Text Key: 151946755
• Report Number: 3008585473-2019-00005
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• PMA/PMN Number: K171599
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11.1500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Disability