MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CANE, OFFSET, BLACK, ALUMINUM

Catalog Number MDS86420

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Concussion (2192)

Event Date 12/31/2023

Event Type  Injury  

Event Description

According to the customer, the metal has pierced through the "rubber cap" at the bottom of the cane, causing the cane to slide, and him to fall "multiple times".

Manufacturer Narrative

According to the customer, the metal has pierced through the "rubber cap" at the bottom of the cane, causing the cane to slide, and him to fall "multiple times".The customer reported he has gone to the emergency room where he was diagnosed with a concussion after a "scan showed swelling on the brain".The customer reported he left the hospital "against medical advice", did not receive treatment for the "concussion", and did not follow up with another provider.This writer advised the customer to stop using the cane.Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Manufacturer Narrative

Investigation conclusions.

• Type of Device: CANE, OFFSET, BLACK, ALUMINUM
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093
• MDR Report Key: 18601489
• MDR Text Key: 334002178
• Report Number: 1417592-2024-00040
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86420
• Device Lot Number: 88522030002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/01/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other