MAUDE Adverse Event Report: UNKNOWN OFFSET HANDLE CANE - BLACK 1616710017; TIPS AND PADS, CANE, CRUTCH AND WALKE

Model Number 40918-6

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been reported by the end user that a 40918-6 cane was received without the tips.

• Brand Name: OFFSET HANDLE CANE - BLACK 1616710017
• Type of Device: TIPS AND PADS, CANE, CRUTCH AND WALKE
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4339472
• MDR Text Key: 5216286
• Report Number: 1531186-2014-06442
• Device Sequence Number: 1
• Product Code: INP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/16/2014,10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 40918-6
• 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: 12/16/2014
• Distributor Facility Aware Date: 10/29/2014
• Date Report to Manufacturer: 12/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other