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

Model Number 7827

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Per provider the frame is tweaked, bent towards the right.

• Brand Name: CANE, CRUTCH AND WALKER TIPS AND PADS
• Type of Device: 890.3790
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4010032
• MDR Text Key: 4779370
• Report Number: 1531186-2014-03236
• Device Sequence Number: 1
• Product Code: INP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/13/2014,07/14/2014

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: 7827
• 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: 08/13/2014
• Distributor Facility Aware Date: 07/14/2014
• Date Report to Manufacturer: 08/13/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other