MAUDE Adverse Event Report: UNKNOWN CAREX DESIGNER OFFSET CANE - BLUE

Model Number FGA51500 BLUE

Device Problem Break (1069)

Patient Problems Fall (1848); Pain (1994)

Event Date 11/10/2016

Event Type  Injury  

Event Description

This customer had experienced a problem with the blue offset cane.This customer/end-user claims that the strap broke on the cane, causing her to fall and get hurt.The event had occurred in the end-user's home, on laminate flooring, coming into her house via entryway.The end-user was already going to the orthopedic doctor for her foot, and was unable to use crutches, so she was instructed to use a cane.She put the strap on her wrist, and reached out to put her hand on the handle and the strap broke, causing her to fall on her right shoulder.She didn't realize her shoulder was hurt until a few days later.She went back to our customer using one of their electric chairs, and showed the rep that the strap broke and she fell.The rep (from our customer) provided her with a new cane and took the broken one.She went to the orthopedic doctor to follow up on her foot, and she told the doctor her shoulder was hurting.The doctor prescribed medicine first, and that didn't work, so then the doctor gave her a cortisone shot.She is still not feeling better.

Event Description

The device was returned for inspection.Upon inspection, the item was found to have been opened and used.The customer stated that the strap broke on the cane causing her to fall and get hurt.The strap is connected to a plastic sleeve that is then secured into the frame of the cane.The plastic sleeve appears to be locked into place with glue.The glue appears to have come undone, resulting in the plastic sleeve and strap detaching from the unit.

• Brand Name: CAREX DESIGNER OFFSET CANE - BLUE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6297006
• MDR Text Key: 66429368
• Report Number: 3012316249-2017-00011
• Device Sequence Number: 1
• Product Code: KHY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 01/31/2017,10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA51500 BLUE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2017
• Distributor Facility Aware Date: 01/04/2017
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other