MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,LUXE,WHITE

Catalog Number	MDS86835W
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	09/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prior to the manufacturer's aware date indicated in this report, this incident had not been previously reported to medline industries, inc.It was reported that while outside of a store waiting to be picked up, the end-user was sitting on the rollator and the "front left wheel of this walker collapsed" resulting in end- user tumbling backwards, landing on her left side and head.It was added, "the front right wheel of the walker became disconnected from the walker, causing it to collapse".Reportedly, the end-user lost consciousness and awoke sitting on a bench outside the store.The end- user reportedly suffered a head injury, a left shoulder injury that required surgical repair, and an exacerbation of her knee that was repaired.The rollator involved in this event was reportedly received from a hospital last 08/08/2016.It was added that it appears that a pin should have been inserted through the frame and through the bolt that held the wheel assembly but was not.Due to the reported event and required medical intervention, this medwatch is being filed.The sample is not available to be returned for evaluation.A definitive 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 or Problem Description
It was reported that the front left wheel of the rollator collapsed resulting in end-user falling and sustaining a left shoulder injury, which required surgical repair.
Additional Manufacturer Narrative
Additional information: sample evaluation: the device was not returned for evaluation; however photos of the actual device were submitted and evaluated.After viewing the photos, the complaint was confirmed.The front right caster was detached from the front leg of the rollator.The rollator appeared to be in used condition based on the appearance of the wear of the wheels, front forks and the frame.Photos show the front caster components without the roll pin.The threaded insert appeared to be stripped near the bottom of the threading.Maintenance and device usage prior to the incident were undetermined.Should the physical sample be received or reviewed by the manufacturer personnel, a full investigation will be conducted.A definitive root cause for the reported issue could not be determined at this time.There is no additional information available.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: ROLLATOR,LUXE,WHITE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8712378
• Report Number: 1417592-2019-00096
• Device Sequence Number: 1234499
• Product Code: ITJ
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDS86835W
• Device Lot Number: 86716010005
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/06/2020
• 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: Required Intervention
• Patient Age: 45 YR