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U.S. Department of Health and Human Services

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

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TIMEWAVER PRODUCTION GMBH HEALY STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
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).
 
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Brand NameHEALY
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
Manufacturer (Section D)
TIMEWAVER PRODUCTION GMBH
MDR Report Key10096340
MDR Text Key193045811
Report NumberMW5094727
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received05/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/27/2020 Patient Sequence Number: 1
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