MAUDE Adverse Event Report: CAREX; FOLDING CRUTCHES

Model Number FGA99500 0000

Device Problems Collapse (1099); Material Twisted/Bent (2981)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

In (b)(6) 2017, the user was severely injured when the crutches collapsed and bent while he was descending a staircase.Manufacturer of device involved with event could not be determined due to lack of serial/lot number information provided.

• Brand Name: CAREX
• Type of Device: FOLDING CRUTCHES
• MDR Report Key: 8176803
• MDR Text Key: 130790653
• Report Number: 3012316249-2018-00063
• Device Sequence Number: 1
• Product Code: IPR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA99500 0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2018
• Distributor Facility Aware Date: 11/13/2018
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other