MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; BASIC, KNEE WALKER,FOUR WHEELED

Catalog Number MDS86000G4

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 06/12/2023

Event Type  Injury  

Event Description

According to the customer, when he engaged the brakes on the knee walker while moving "one of the brakes broke" causing him to fall onto his "right knee and stomach.".

Manufacturer Narrative

According to the customer, when he engaged the brakes on the knee walker while moving "one of the brakes broke" causing him to fall onto his "right knee and stomach." the customer reported he went to the hospital by ambulance and was given "morphine" for pain and an x-ray was taken.The customer reported the x-ray did not show any "broken bones" but he has "bruising and scratches" on his knee.The customer reported he has continued to take over-the-counter "tylenol" for the pain.No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: BASIC, KNEE WALKER,FOUR WHEELED
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17239366
• MDR Text Key: 318223166
• Report Number: 1417592-2023-00273
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86000G4
• Device Lot Number: 16422070001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Date Manufacturer Received: 06/12/2023
• 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