MAUDE Adverse Event Report: UNKNOWN CRUTCH; 890.3150

Model Number UNKNOWN

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Date 09/23/2014

Event Type  No Answer Provided  

Event Description

End user's wife advised when her husband was walking in the kitchen the replacement crutches wobbled and he fell.No apparent injuries, no medical attention sought.End user is a recent amputee.He goes to physical therapy and makes them aware when he falls.They are not sure of model number but thinks it is adjust.

• Brand Name: CRUTCH
• Type of Device: 890.3150
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4180073
• MDR Text Key: 20657679
• Report Number: 1531186-2014-04910
• 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: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/15/2014,09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• 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: 10/15/2014
• Distributor Facility Aware Date: 09/25/2014
• Date Report to Manufacturer: 10/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other