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

Catalog Number 11.1500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Date 10/02/2014

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 anonymous customer review date shown on the internet.This review showed the gel pads were supplied to specification.

Event Description

The pads are fine but they give me a bad rash and others may experience that as well.

• 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: 8843245
• MDR Text Key: 152760785
• Report Number: 3008585473-2019-00006
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• 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: 07/30/2019

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11.1500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 07/30/2019
• 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