MAUDE Adverse Event Report: TIMEWAVER PRODUCTION GMBH HEALY; STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/07/2020

Event Type  Injury  

Event Description

I purchased the healy.The website is www.Healyworld.Net/in/wellness video is (b)(6) i ordered it online and it arrives in my home in (b)(6).It is a 'medically certified' wearable bracket that connects to frequency generator.The producers stated that it could help with my depression.I stopped taking my medication thinking the device could replace them.After 4 weeks my symptoms got worse and i am now on a higher dose.This product completely failed in its therapeutic claims.When my wife saw what was happening to me, she threw out the device and forced me back on my medication.I am now stable again, but at a higher dosage than previously.Note: timewaver and healy (b)(4) are (b)(4).Manufacturing partners for (b)(4).Fda safety report id# (b)(4).

• Brand Name: HEALY
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): TIMEWAVER PRODUCTION GMBH
• MDR Report Key: 10096340
• MDR Text Key: 193045811
• Report Number: MW5094727
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 66