MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-CANE,T-HANDLE,FLORAL PRINT

Catalog Number MDS86435FL

Device Problem Material Integrity Problem (2978)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 08/05/2023

Event Type  Injury  

Event Description

Fall resulting in fracture.

Manufacturer Narrative

It was reported that the customer fell while walking with the device due to "the rubber tip are worn".It was reported that the fall resulted in a fracture that required surgery.It was reported that after surgery, rehab was required.A sample was requested to be returned for 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.

• Type of Device: DBD-CANE,T-HANDLE,FLORAL PRINT
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17855457
• MDR Text Key: 324739400
• Report Number: 1417592-2023-00396
• 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
• Report Date: 10/02/2023

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 Catalogue Number: MDS86435FL
• Device Lot Number: 5121108002
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 10/02/2023
• 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