MAUDE Adverse Event Report: DRIVE WALKER, MECHANICAL

Device Problems Loose or Intermittent Connection (1371); Protective Measures Problem (3015)

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

Event Type  malfunction  

Event Description

Provider states the enduser alleges the walker will not lock.Provider sales sold until to enduser in (b)(6) 2013 and will call back with a lot number.The caller has no further information to provide.No injury alleged.(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
• MDR Report Key: 17537163
• MDR Text Key: 321274667
• Report Number: MW5144043
• 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: 09/11/2015

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