FDA Adverse Event Injury Summary report: N

FITNESS GEAR INVERSION TABLE

MDR report key: 5537522 · Received March 28, 2016

Report

Report Number
MW5061365
Event Type
Injury
Date Received
March 28, 2016
Date of Event
February 2, 2015
Report Date
March 28, 2016
Manufacturer
PARADIGM FITNESS EQUIPMENT, INC.
Product Code
HST
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
SC, US
Reporter Occupation
0

Narratives

Description of Event or Problem · 1

ON (B)(6) 2015, MR. (B)(6) WAS UTILIZING A DICK'S SPORTING GOODS MODEL STE00118FG INVERSION TABLE IN HIS BEDROOM, AS HE HAD DONE ROUTINELY TWICE A DAY SINCE (B)(6) 2014, FOR RELIEF OF LOW BACK PAIN. WHEN HE INVERTED ON THIS DAY, THE ANKLE LOCKING DEVICE ON THIS EQUIPMENT FAILED, THROWING HIM HEAD FIRST ONTO THE FLOOR. HE LIVES ALONE. HE WAS IMMEDIATELY PARALYZED FROM THE NECK DOWN AND LAY ON THE FLOOR OF HIS BEDROOM FOR OVER 90 MINUTES WHILE HE ATTEMPTED TO TURN OVER HIS CELL PHONE WITH HIS CHIN AND MOUTH. HE WAS FINALLY SUCCESSFUL IN TURNING OVER THE CELL PHONE AND DIALED 911 WITH HIS NOSE. HIS CHEEK FORMED A RUG BURN FROM ATTEMPTING TO ACCESS HIS CELL PHONE. HE BELIEVED FOR OVER AN HOUR THAT HE MIGHT DIE ON HIS BEDROOM FLOOR AND MIGHT NOT BE DISCOVERED FOR DAYS. HE WAS TAKEN TO (B)(6), WHERE HE GRADUALLY BEGAN TO REGAIN FEELING IN HIS EXTREMITIES. HE WAS FOUND TO HAVE A FRACTURE OF HIS C3 VERTEBRAL BODY, A FRACTURE OF THE C7 VERTEBRAE, AND DISC HERNIATIONS WITH SEVERE SPINAL CORD STENOSIS AT C4-5 AND C6-7. HE WAS IMMEDIATELY TRANSFERRED TO (B)(6), WHERE HE WAS ADMITTED FROM (B)(6) FOR NEUROLOGICAL EVALUATION. IT WAS DETERMINED THAT THE SWELLING NEEDED TO BE CONTROLLED, SO SURGERY WAS DEFERRED, AND HE WAS PLACED IN MIAMI J COLLAR, AND HE WAS DISCHARGED BACK TO (B)(6) HOSPITAL WHERE HE WAS ADMITTED FROM (B)(6), DURING WHICH TIME HE UNDERWENT 3 HOURS PER DAY OF ACUTE REHAB THERAPY. HE RETURNED TO (B)(6) ON (B)(6), WHERE HE UNDERWENT SURGERY FOR FUSION OF THE C4-5, C5-6 AND C6-7 WITH PLATES AND SCREWS. HE REMAINED AS AN INPATIENT AT (B)(6) UNTIL (B)(6). HE RETURNED TO (B)(6), WHERE HE PARTICIPATED IN INTENSE PHYSICAL THERAPY FROM (B)(6) 2015. HE RETURNED TO (B)(6) IN EARLY (B)(6) AND, AS HE CONTINUED TO HAVE ROM LIMITATION, NUMBNESS AND RADIATING PAIN, HE WAS PRESCRIBED ANOTHER SESSION OF PHYSICAL THERAPY FROM (B)(6) 2015. HE IS CURRENTLY UNDER THE CARE OF DR. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
185852 FITNESS GEAR INVERSION TABLE FITNESS GEAR INVERSION TABLE HST PARADIGM FITNESS EQUIPMENT, INC. FGIT-300

Patients

Seq Age Sex Outcome Treatment
1 73 YR Hospitalization