MAUDE Adverse Event Report: DRIVE MEDICAL WALKER, MECHANICAL

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Provider states that the consumer was using the rollator and the horizontal bar broke causing them to be jolted forward.Provider was not made aware of any patient injury.No additional information provided, provider will contact consumer for model.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: WALKER, MECHANICAL
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DRIVE MEDICAL
• MDR Report Key: 17528962
• MDR Text Key: 321311718
• Report Number: MW5135891
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2015

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1