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

Catalog Number MDS86420H

Device Problem Material Twisted/Bent (2981)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/11/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, on (b)(6) 2023 she left her husband alone with a cane and a walker in front of him, and returned to find her husband on the ground and the cane "bent".The customer reported she called "911", the paramedics performed "cpr and used a defibrillator" but, they were "unable to save him".The customer reported 28 days prior to the incident her husband became "weak", was diagnosed with "a-fib", and "had fluid around his heart".According to the customer the morning of the reported incident, she was "unable to get him up" because he became increasingly "weaker".According to the customer she does not believe the cane or the fall caused his death.Sample was requested for return evaluation.No additional information is available at this time.It has been determined that the reported device was involved in an event that lead to a serious injury or death therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, on 3/11/2023 she left her husband alone with a cane and a walker in front of him, and returned to find her husband on the ground and the cane "bent".

Manufacturer Narrative

Updated h6: 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 drive; northfield, IL 60093
• MDR Report Key: 16765230
• MDR Text Key: 313537296
• Report Number: 1417592-2023-00171
• 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: 07/06/2023

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: MDS86420H
• Device Lot Number: 88521120001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other