MAUDE Adverse Event Report: UNKNOWN NARROW BASE QUAD CANE 1616710022

Model Number 3920-2

Device Problems Break (1069); Collapse (1099)

Patient Problems Fall (1848); Injury (2348)

Event Type  Injury  

Event Description

It was reported by a family member of the end user that a 3920-2 cane collapsed and broke on the end user, causing her to fall to the ground.There was no bleeding, but the end user hurt her leg.No report of medical intervention.

• Brand Name: NARROW BASE QUAD CANE 1616710022
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4462053
• MDR Text Key: 5324975
• Report Number: 1531186-2015-00640
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/28/2015,05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3920-2
• 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: 01/28/2015
• Distributor Facility Aware Date: 05/09/2014
• Date Report to Manufacturer: 01/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 68