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

Catalog Number 11.1500

Device Problems Loss of or Failure to Bond (1068); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 04/09/2018

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.

Event Description

These are thin.They don't adhere well.And, they are so uneven that you end up with horrible shooting pains in some areas while using them.I appreciate the price, but very unhappy that they're not returnable.Their inconsistency makes them unusable for me.I don't recommend these.

• 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: 8796178
• MDR Text Key: 151265286
• Report Number: 3008585473-2019-00003
• 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
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• 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