MAUDE Adverse Event Report: FITNESS GEAR INVERSION TABLE

Model Number FGIT-300

Device Problem Detachment Of Device Component (1104)

Patient Problem Head Injury (1879)

Event Date 12/20/2014

Event Type  Injury  

Event Description

Was using the paradigm health and wellness inc.Inversion table.Went inverted at a 180 degree angle for about 45 seconds when the ankle braces released the user and he landed on his head.Paradigm health and wellness, inc.

• Brand Name: FITNESS GEAR INVERSION TABLE
• Type of Device: FITNESS GEAR INVERSION TABLE
• MDR Report Key: 5064132
• MDR Text Key: 25288268
• Report Number: MW5056033
• Device Sequence Number: 1
• Product Code: HST
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGIT-300
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HYDRIN
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 77