FDA Adverse Event Malfunction Summary report: N

NOVA ROLLATOR

MDR report key: 23084932 · Received September 18, 2025

Report

Report Number
MW5176238
Event Type
Malfunction
Date Received
September 18, 2025
Date of Event
September 9, 2025
Manufacturer
NOVA ORTHO-MED, INC.
Product Code
ITJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

PURCHASED A NEW NOVA ROLLATOR WALKER ON (B)(6) 2025 FOR $255.00 FROM (B)(6), IN PREPARATION FOR A HIP PROCEDURE THAT WOULD REQUIRE THE USE OF THIS PIECE OF EQUIPMENT. I TRIED IT OUT IN STORE PRIOR TO PURCHASING IT AND NOTICED THAT ONE OF THE BRAKES FELT TOO TIGHT. THE SALESPERSON, (B)(6), ASSURED ME THAT IT WAS NORMAL FOR IT TO FEEL TIGHT AT FIRST BUT THAT IT "WOULD LOOSEN UP WITH TIME". AS I HAVE NEVER OWNED A WALKER BEFORE I TRUSTED THE SALESPERSON. ON (B)(6) 2025, UPON MY DISCHARGE AND THE FIRST TIME I USED THE DEVICE, I WAS UNABLE TO PUSH THE WALKER STRAIGHT AS THE BRAKE WOULD NOT DISENGAGE ON THE RIGHT SIDE CAUSING THE WALKER TO WANT TO GO TO THE RIGHT IN CIRCLES. IT WAS ALSO CUTTING PLASTIC FROM THE WHEELS LEAVING BLACK SHAVINGS EVERYWHERE. AFTER IT NEARLY CAUSED ME TO FALL FROM BEING DEFECTIVE, I CALLED (B)(6) AND WAS TOLD TO BRING IT UP AND THEY WOULD REPAIR IT. STILL RECOVERING FROM MY PROCEDURE, MY SON BROUGHT THE WALKER BACK TO THE STORE ON (B)(6) 2025 AND WAS TOLD THAT THEY WOULD HAVE TO CONTACT A NOVA REPRESENTATIVE SINCE THEY DON'T DO RETURNS AND THEY WERE UNABLE TO REPAIR IT DUE TO IT HAVING A DEFECTIVE WHEEL. THEY WOULD NOT RETURN THE WALKER SINCE IT WAS DEFECTIVE AND COULD CAUSE INJURY. HAD TO FOLLOW UP THREE DAYS LATER AS THERE WAS NO CONTACT FROM (B)(6) AND WAS TOLD THAT THEY HAVEN'T HEARD FROM THE REPRESENTATIVE. I WAS KNOWINGLY SOLD A DEFECTIVE PIECE OF MEDICAL EQUIPMENT THAT POSED A RISK OF INJURY AND AS OF TODAY (B)(6) 2025 I STILL DON'T HAVE MY WALKER THAT IS A CRITICAL PART OF MY RECOVERY, SAFETY, AND MOBILITY. I HAVE SERIOUS CONCERNS REGARDING THEIR LACK OF HONESTY ABOUT THE INTEGRITY OF THEIR EQUIPMENT AND THEIR LACK OF CONCERN FOR PATIENT SAFETY. RETAILERS OF MEDICAL EQUIPMENT COMPANIES HAVE A LEGAL OBLIGATION TO NOT SELL DEFECTIVE PRODUCTS AS IT COULD CAUSE HARM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
317590 NOVA ROLLATOR WALKER, MECHANICAL ITJ NOVA ORTHO-MED, INC. 4256BL

Patients

Seq Age Sex Outcome Treatment
1 Female Other