FDA Adverse Event Injury Summary report: N

ROMTECH PHYSICAL THERAPY PEDAL MACHINE

MDR report key: 18066903 · Received November 2, 2023

Report

Report Number
MW5147749
Event Type
Injury
Date Received
November 2, 2023
Date of Event
October 26, 2023
Report Date
October 26, 2023
Manufacturer
ROM TECHNOLOGIES, INC.
Product Code
IKK
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

WAS GIVEN A 2ND GENERATION ROM (RANGE OF MOTION) BIKE ON THE 19TH OF OCTOBER THROUGH A VENDOR CALLED (B)(4) TO PERFORM PHYSICAL THERAPY WITH AFTER HAVING A LEFT KNEE TOTAL REPLACEMENT ON THE 20TH OF OCTOBER. BEGAN UP TO 5, 12 MINUTE SESSIONS A DAY OF PASSIVE AND ACTIVE BICYCLE PHYSICAL THERAPY AT THE BIKE ON THE 21ST OF OCTOBER AFTER BEING RELEASED FROM THE HOSPITAL WHERE I DID AN OVERNIGHT STAY. I USED THE ROM BIKE SEVERAL TIMES A DAY SINCE THEN, THERE WAS NO PROBLEMS WITH THE BIKE AT SET UP, AND THE FUNCTION OF THE BIKE HAS BEEN FLUID AND CONSISTENT WHEN INSTRUCTED TO PEDDLE FASTER THERE WAS A SMALL PLASTIC SCRATCHING SOUND, BUT IT WAS FAINT AND DIDN'T SEEM TO CAUSE ANY RESTRICTIONS IN MOVEMENT. HOWEVER NEAR THE END OF MY 3RD SESSION FOR THE DAY ON 26 OCTOBER AT APPROXIMATELY 12:30PM I WAS IN THE ACTIVE PEDDLING PORTION OF THE THERAPY WHEN WITHOUT WARNING AND WITH FORCE MY LEFT HEEL JAMMED INTO THE GROUND AND HYPEREXTENDED AT THE KNEE CAUSING SERVER SCALE 10 PAIN IN MY KNEE AREA! WHAT I NOTICED HAD HAPPENED IS THE LEFT PEDAL HAD COME LOOSE AND WAS NOW SITTING ON THE FLOOR FURTHER AWAY FROM ME. MY THEORY IS THAT IT WAS NEVER SCREWED IN PROPERLY AND CAME LOOSE OR HAD UNSCREWED DURING THE THERAPY SESSIONS AND FELL OUT DURING MY SESSION. THE PAIN IS ELEVATED IN THE JOINT NOW, THE PROSTHESIS FEELS A LITTLE MOBILE TOO, MY HEEL HAS A SEVER BRUISED FEELING NOW TOO. I HAVE ASKED (B)(4) TO GET ME THE NAME AND NUMBER OF THE PERSON I NEED TO SPEAK TO FILE A FORMAL INCIDENT REPORT. I FEEL LIKE THE NEGATIVE IMPACT OF THIS INCIDENT COULD HAVE BEEN MUCH WORSE AND COULD HAVE LED THE DEATH OF A USER IF THEY DO BREAK THEIR PROSTHESIS OUT OF THEIR BONES AND PERHAPS BLEED TO DEATH OR DIE OF SHOCK. JUST HAVE NUMEROUS PHOTOS JUST AFTER THE TIME OF INCIDENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1952189 ROMTECH PHYSICAL THERAPY PEDAL MACHINE SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK ROM TECHNOLOGIES, INC. 10100

Patients

Seq Age Sex Outcome Treatment
1 54 YR Male Other PASSIVE / ACTIVE PHYSICAL THERAPY PEDAL BIKE.| APAP (AUTOMATIC POSITIVE AIRWAY PRESSURE).