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

Catalog Number	WRX449724
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	02/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a customer was using their rollator on (b)(6) 2017 and the wheel fell off resulting in the customer falling to the ground which reportedly resulted in the customer breaking her hip.The customer required surgery to repair the hip and was hospitalized for rehab before she was brought home.The customer now has a full time caregiver to take care of her at home.The customer's daughter reported that she did not report the incident to the retail store or manufacturer until approximately one month ago when the financial burden started to become overwhelming.A sample was returned for evaluation however the customer reported issue was not confirmed.Due to the reported incident and subsequent need for surgical intervention, this medwatch is being filed.Should the sample be returned or additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Wheel fell off resulting in the customer falling to the ground which reportedly resulted in the customer breaking her hip.

• Common Device Name: ROLLATOR,SUPER LIGHT,250LB CAP
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; 3 lakes dr; northfield IL 60093
• MDR Report Key: 7451139
• Report Number: 1417592-2017-00059
• Device Sequence Number: 13488999
• Product Code: ITJ
• UDI-Device Identifier: 00311917124711
• UDI-Public: 311917124711
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: WRX449724
• Device Lot Number: 88516040002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 89 YR
• Patient Weight: 59