MAUDE Adverse Event Report: DRIVE; CANE

Device Problem Detachment Of Device Component (1104)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Type  Injury  

Event Description

(b)(4) received notification of an incident involving a cane that (b)(4) distributes.On two occasions, the enduser was using the cane in her home when allegedly, one of the feet detached causing her to fall onto her face.The patient sustained a bruised right eye and medical attention was not sought.The item has not been returned therefore no further evaluation has been conducted.

• Brand Name: DRIVE
• Type of Device: CANE
• MDR Report Key: 6254020
• MDR Text Key: 64889949
• Report Number: 2438477-2017-00002
• Device Sequence Number: 1
• Product Code: IPS
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/16/2017,12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 01/16/2017
• Distributor Facility Aware Date: 12/19/2016
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR