MAUDE Adverse Event Report: NOVA MEDICAL PRODUCTS / NOVA ORTHOPEDIC & REHABILITATION APPLIANCE INC. (VIETNAM) MIGHTY MACK HEAVY DUTY ROLLATOR WALKER; WALKER, MECHANICAL

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Unspecified Tissue Injury (4559)

Event Date 07/11/2021

Event Type  malfunction  

Event Description

Patient fell down off walker when she was trying to break.Breaks on both sides of walker found not to be working.Patient fall resulted in her arm being placed in a cast.Visual inspection of the device found that, when the brakes were engaged, the wheels were able to roll freely.Review of the patient/device record shows that the device was purchased nearly two years ago, with no requests for service or inspection since the initial delivery.Determined to be the result of a lack of maintenance and normal wear of device components.Fda safety report id# (b)(4).

• Brand Name: MIGHTY MACK HEAVY DUTY ROLLATOR WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): NOVA MEDICAL PRODUCTS / NOVA ORTHOPEDIC & REHABILITATION APPLIANCE INC. (VIETNAM)
• MDR Report Key: 14375174
• MDR Text Key: 291638485
• Report Number: MW5109648
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 149 KG
• Patient Ethnicity: Non Hispanic