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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTREME PRODUCTS GROUP HEALTH GEAR INVERSION TABLE APPARATUS, TRACTION, NON-POWERED

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EXTREME PRODUCTS GROUP HEALTH GEAR INVERSION TABLE APPARATUS, TRACTION, NON-POWERED Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Fall (1848); Pain (1994)
Event Date 08/28/2017
Event Type  Injury  
Event Description
I have an inversion table called "health gear" by extreme products group that i purchased through (b)(4). I use it regularly and noticed from the onset that the consumer must make sure that i depress the locking mechanism that secures my feet. Last night, i got on it as normal but for some reason it had not locked in. It was when i let one arm go back and one hand on the unit that the ankle looks broke free and launched me to the cement floor. By the time i figured out what was going on. It didn't have enough strength to stop the fall. I ended up in the emergency room resulting in a bunch of x-rays and cat scan leaving me in immense head, shoulder, back and mid section pain. I'm glad i didn't get paralyzed.
 
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Brand NameHEALTH GEAR INVERSION TABLE
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
EXTREME PRODUCTS GROUP
MDR Report Key6834572
MDR Text Key84353892
Report NumberMW5071886
Device Sequence Number1
Product Code HST
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 08/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/31/2017 Patient Sequence Number: 1
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