MAUDE Adverse Event Report: ROSCOE CANE; CANE/CANE TIP

Device Problem Crack (1135)

Patient Problem Pain (1994)

Event Date 02/03/2016

Event Type  Injury  

Event Description

The end-user was using a roscoe cane (part number is unknown, however, it has been reported that our name [roscoe medical] was on the cane).The tip of the cane cracked, causing the end-user to fall and injure her right knee.The customer had a doctor's appointment on (b)(4) 2016 because her knee was still bothering her.The customer did go to the doctor, and the doctor wants to do an mri.The end-user had foot surgery on (b)(6) 2016, and is still in a lot of pain from her foot surgery - the doctor wants to wait until after her foot heals until following through with an mri.

• Brand Name: ROSCOE CANE
• Type of Device: CANE/CANE TIP
• MDR Report Key: 5477875
• MDR Text Key: 39628344
• Report Number: 3005182235-2016-00002
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 03/03/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 100