MAUDE Adverse Event Report: STANDARD WALKER; WALKER, MECHANICAL

Device Problems Break (1069); Unintended Movement (3026); Sharp Edges (4013)

Patient Problems Fall (1848); Skin Tears (2516)

Event Date 06/20/2022

Event Type  malfunction  

Event Description

Walker being used and fastener on top bar (left side) broke causing walker support on left to swing out and resident fell.There was skin tear caused by exposed fastener.

• Brand Name: STANDARD WALKER
• Type of Device: WALKER, MECHANICAL
• MDR Report Key: 14914775
• MDR Text Key: 295362068
• Report Number: MW5110664
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/30/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Race: White