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

Catalog Number WRX449724

Device Problem Component Falling (1105)

Patient Problem Hip Fracture (2349)

Event Date 02/18/2017

Event Type  Injury  

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 Description

Wheel fell off resulting in the customer falling to the ground which reportedly resulted in the customer breaking her hip.

• Type of Device: ROLLATOR,SUPER LIGHT,250LB CAP
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes dr; northfield, IL 60093 ; 8476434960
• MDR Report Key: 7451139
• MDR Text Key: 106194968
• Report Number: 1417592-2017-00059
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00311917124711
• UDI-Public: 311917124711
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 04/23/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR
• Patient Weight: 59