MAUDE Adverse Event Report: DRIVE WALKER, MECHANICAL

Device Problem Material Twisted/Bent (2981)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Type  Injury  

Event Description

Caller states that his wife's rollator frame is bent above where the leg attaches to the frame, right front.End user states she was sitting on the rollator in her doctors office in the waiting room, she went to move the rollator and sit back down when this leg bent and she fell out of the rollator face down, got a black eye, left elbow and hands have black and blue bruises.End user states they called emt to help her up and check her out.Caller states they could not locate a lot number.Consumer advised their rollator says drive but they have an invacare owners manual.Consumer was referred to drive to discuss the product and advised the manual is not correct for the product.Caller states the word drive is embroidered on the backrest of their product.(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: 17534336
• MDR Text Key: 321162343
• Report Number: MW5141238
• 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: 01/03/2018

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
• Patient Age: 76 YR