MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,STEEL,KNOCK-DOWN

Catalog Number MDS86850ESKD

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that a front wheel of the rollator detached and the end-user experienced a backward fall.Despite multiple good faith attempts the end-user was unable or unwilling to provide additional information to the manufacturer.Although no serious injury or medical intervention was originally reported, it was indicated in the original report that the end-user was admitted to a hospital following the fall incident as it was unsure if her "stint was dislodged." no sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for hospitalization, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a front wheel of the rollator detached and the end-user experienced a backward fall.

Manufacturer Narrative

The end-user was able to be contacted and provided additional information to the manufacturer.Reportedly, as the end-user was walking, the front right wheel of the device detached and the end-user experienced a backward fall and hit her head on the ground.The end-user was evaluated at a local hospital and was admitted to the hospital for two (2) days of observation due to a concern that a cardiac stent, which was recently placed, may have been dislodged during the fall.During her hospital stay, the end-user experienced bruising to the chest but was reportedly informed that no issues with her cardiac stent were identified.The end-user was discharged home with no further follow-up or incident reported.No sample has been returned to the manufacturer for evaluation at this time.If additional relevant information becomes available another supplemental medwatch will be filed.

Manufacturer Narrative

A sample was returned to the manufacturer and evaluation has been completed.Based on the condition of the returned rollator, it could not be determined what type of maintenance has been performed on the device.During inspection of the brakes, the right side seemed to be slightly out of adjustment.The backrest attached and detached without any issues and the seat upholstery appeared to be in used condition with a few minor scratches present.The rollator was noted to have multiple scratches and dents which were likely to have been caused by impact.The folding mechanism of the device was found to function properly at the time of inspection with the rollator opening and closing with ease.Once assembled, all four wheels were tight and secure with the front wheels and the roll pins still set in the correct position upon receipt.All four wheels were noted to be covered with a significant amount of dirt, grime, and hair.The reported product problem/issue was unable to be confirmed and a root cause was not determined.If additional relevant information becomes available another supplemental medwatch will be filed.

• Type of Device: ROLLATOR,STEEL,KNOCK-DOWN
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11891364
• MDR Text Key: 255941417
• Report Number: 1417592-2021-00094
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850ESKD
• Device Lot Number: 05420070001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 64