MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DBD-KNEE WALKER,FOUR WHEELED

Catalog Number MDS86000G3

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the rear left wheel of the knee walker detached as the end-user was propelling forward.When the wheel detachment occurred, the end-user reportedly became unbalanced and he experienced a fall.The end-user reported that he went to an emergency department (ed) where unspecified "x rays and couple of tests" were performed.No acute findings or hospital admission were reported and he was reportedly started on physical therapy (pt) following the ed visit.The end-user also reported that he was evaluated at an urgent care center, however, no further diagnostic exams or prescriptive treatments were reported.The end-user has experienced soreness with bruising to his right hip and lower back.No sample has been returned to the manufacturer for evaluation and a root cause was not determined at this time.Due to the reported need for pt this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a wheel on the knee walker detached.

• Type of Device: DBD-KNEE WALKER,FOUR WHEELED
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12433234
• MDR Text Key: 272473427
• Report Number: 1417592-2021-00171
• 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: consumer
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86000G3
• Device Lot Number: 86720090006
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 163