MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR

Catalog Number MDS86825SLB

Device Problem Material Separation (1562)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

End-user was walking across a room when a screw came out and the wheel fell off.The rollator fell to the left; end-user lost balance and fell into a wooden table.End-user was transported to the local emergency department and an x-ray showed three rib fractures.End-user was admitted to the hospital for treatment and physical therapy.A sample was not returned; end-user stated her husband replaced and secured the screw by using lock-tight.End-user is currently still using the rollator.A root cause cannot be determined at this time.Due to the reported incident and in an abundance of caution this medwatch is being filed.

Event Description

It was reported the left front wheel of a rollator fell off and caused end-user to fall.

• Type of Device: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093
• MDR Report Key: 6525737
• MDR Text Key: 234649803
• Report Number: 1417592-2017-00023
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86825SLB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2017
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 77 KG