MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,SUPER LIGHT,250LB CAP.

Catalog Number WRX449724

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/06/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that end-user stood up and began to walk on a rug surface when the unidentified wheel of the rollator came off.The end-user fell, emergency medical service was called and end-user was taken to a hospital.The end-user reportedly sustained a right femur fracture, which required a 12-inch plate and a fixator implanted.The end-user is doing rehab at an assisted living facility.The rollator was reportedly used for approximately five months prior to this event occurring.Due to the reported femur fracture and required medical intervention, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the rollator's wheel came off while end-user was walking using the rollator.The end-user fell and sustained right femur fracture.

• Type of Device: ROLLATOR,SUPER LIGHT,250LB CAP.
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8821386
• MDR Text Key: 152031739
• Report Number: 1417592-2019-00104
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 10311917124718
• UDI-Public: 10311917124718
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: WRX449724
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• 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): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 88