MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; KNEE WALKER,WEIL,300LB WEIGHT CAP

Catalog Number MDS86000

Device Problem Device Fell (4014)

Patient Problem Pain (1994)

Event Date 09/04/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported by the end user that while using the device, the tire fell off the knee walker resulting in the end user falling on the ground.The end user reported that when she fell, she hit her head and knee and twisted her left ankle which was sustained a bruise.It was reported that later that evening the end user went to the emergency room for treatment due to pain and underwent x-rays and (unknown) pain injections to her (unspecified) knee.The end user did not require admission to the hospital.The device was not returned to the manufacturer for evaluation.No additional information was provided at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported by the end user that while using the device, the tire fell off the knee walker resulting in the end user falling on the ground.

• Type of Device: KNEE WALKER,WEIL,300LB WEIGHT CAP
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 12673663
• MDR Text Key: 280085208
• Report Number: 1417592-2021-00198
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/21/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/21/2021
• 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): Other
• Patient Age: 62 YR
• Patient Weight: 54