MAUDE Adverse Event Report: UNKNOWN CANE, CRUTCH AND WALKER TIPS AND PADS; 890.3790

Model Number 40918-6

Device Problem Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Cane 40918-6 tip is worn from walking on the sidewalk and dragging it.

• Brand Name: CANE, CRUTCH AND WALKER TIPS AND PADS
• Type of Device: 890.3790
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4126861
• MDR Text Key: 4937056
• Report Number: 1531186-2014-04542
• 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: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2014,09/09/2014

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?: 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: 09/29/2014
• Distributor Facility Aware Date: 09/09/2014
• Date Report to Manufacturer: 09/29/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other