MAUDE Adverse Event Report: LEG BRACE WALKER

Device Problem Insufficient Information (3190)

Patient Problem Ambulation Difficulties (2544)

Event Date 02/18/2000

Event Type  Injury  

Event Description

At eleven am (b)(6) 2000, i got out of bed to go to work, my legs didn't work.My mother came into see if i was up, she couldn't get me off the floor.Called 911, they took me to (b)(6).Round case with pills in case to take, per day.Pill daily 1x oral.Date the person first started taking or using the product: 1998.Date the person stopped taking or using the product: (b)(6) 2000.Did the problem stopped stop after the person reduced the dose or stopped taking or using the product? yes.

• Brand Name: LEG BRACE WALKER
• Type of Device: LEG BRACE WALKER
• MDR Report Key: 5074987
• MDR Text Key: 25850044
• Report Number: MW5056110
• Device Sequence Number: 1
• Product Code: ITJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2015

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
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 48 YR
• Patient Weight: 64