MAUDE Adverse Event Report: CAREX QUAD CANE

Device Problems Bent (1059); Break (1069); Collapse (1099)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 07/07/2015

Event Type  Injury  

Event Description

Email received by customer service on (b)(6) 2015: i bought your carex quad cane 3-4 months ago because i have falls and my doctor said the quad would be safer.Two weeks ago tonight i was using my cane and started to fall and was trying to get hand on counter but the cane bent and caused me to fall after all.The bad part is it made be fall on the sharp base at the bottom.It caused a zagged laceration that required 18 stitches at the er.Er doc was concerned it was going to a problem for infection and would probably need wound care.(b)(6) had to go to another er and due to infection doc had to take stitches out and open up due to infection.Went to doc yesterday was admitted to hospital due to infection and needing wound care.Followup call to consumer on (b)(6) 2015 obtained the following additional information: cane was thrown away house.Consumer has photos of cane and leg but does not have a way of emailing them at this time.She indicated the cane broke on the shaft and she fell against the bottom portion of the cane not realizing how jagged it was and it tore her leg.She has had both knees replaced and one hip with the other hip being bad.At her daughter's house in tx when cane broke.She is currently using a walker.Weight of consumer is 240 lbs.Product description is as follows: logo of carex is on the cane.Quad silver cane.Softer handle.Consumer is currently in the hospital.Dr.Came in the room and she ended the call.On (b)(6) 2015 - called consumer to provide address to send photos.She will mail them to me directly.Incident happened on (b)(6) 2015.Unsure if she needs plastic surgery as they had to remove stitches due to infection.Team of 3 physicians attended her.

• Brand Name: CAREX QUAD CANE
• Type of Device: CANE
• MDR Report Key: 4955754
• MDR Text Key: 6250401
• Report Number: 2182780-2015-00008
• 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
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 07/29/2015
• Distributor Facility Aware Date: 07/21/2015
• Device Age: 3 MO
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 109