MAUDE Adverse Event Report: N/A

Model Number N/A

Device Problems Collapse (1099); Solder Joint Fracture (2324)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); Tooth Fracture (2428)

Event Type  Injury  

Event Description

In 2016, the end-user allegedly wrote a letter to carex health brands regarding the following: a walker, without any warning, collapsed on the end-user.The metal on the walker is reported as having actually severed.At the time of the event, the end-user is reported as having been using the walker to go from the den to the kitchen - the user was able to break her fall by catching onto a nearby chair.The end-user reports that she was diagnosed with rheumatoid arthritis in (b)(6) 2015, and up until the time of this event, only her right leg gave her trouble.She used the walker to aid with her mobility.She reported as having referred to her left leg as her "good leg" because it was pain free - since the accident/event, this is no longer reported as being true.Her left foot is reported as now hurting and not working as well.The end-user reports that when she fell, the sudden jolt made her partial denture come out of her mouth, hitting the floor.

• Brand Name: N/A
• Type of Device: N/A
• MDR Report Key: 6407868
• MDR Text Key: 70055143
• Report Number: 3012316249-2017-00024
• 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: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2017
• Distributor Facility Aware Date: 02/18/2017
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention