MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. QUAD CANE TIP

Catalog Number MDS86424W

Device Problem Naturally Worn (2988)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/24/2014

Event Type  Injury  

Event Description

The cane tip wore through and the end user fell.

Manufacturer Narrative

While walking at home, the end user reported that she fell when the cane tip wore through.She suffered a bruise to her face and knee and fractured her right hand.The fracture was treated with a brace.She was hospitalized for two days for observation and was discharged home with physical therapy.No lot number was provided and the sample was not returned for evaluation.No photos were sent.The product number for the cane was not reported.She stated it is a quad cane.The condition of the other three tips is not known.In the absence of a sample, a root cause has not been determined.

• Brand Name: QUAD CANE TIP
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4006562
• MDR Text Key: 4689361
• Report Number: 1417592-2014-00075
• Device Sequence Number: 1
• Product Code: INP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/29/2014

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: MDS86424W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 08/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 77