MAUDE Adverse Event Report: UNKNOWN QUICK CHANGE CRUTCH ADULT 9153618192; TIPS AND PADS, CANE, CRUTCH AND WALKE

Model Number 8115-A

Device Problems Unstable (1667); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

Provider states the handgrips will not stay tightened.

• Brand Name: QUICK CHANGE CRUTCH ADULT 9153618192
• Type of Device: TIPS AND PADS, CANE, CRUTCH AND WALKE
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4383340
• MDR Text Key: 16174162
• Report Number: 1531186-2014-07104
• 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
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/31/2014,12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8115-A
• 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: 12/31/2014
• Distributor Facility Aware Date: 12/10/2014
• Date Report to Manufacturer: 12/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other