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

Catalog Number MDS86850ESKD

Device Problems Material Fragmentation (1261); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the right rear rollator wheel was locking up and shedding metal shavings.According to the end-user, a metal shaving entered his left fifth toe.He went to a local va hospital where he received an unspecified treatment and was then discharged home with a prescription for an unspecified antibiotic.No further treatment or follow-up care in relation to the incident occurred.A sample was returned and investigated.Inspection of the brakes found that they seemed to be slightly out of adjustment.When the brakes were set, the rear wheels would continue to rotate.The backrest attached and detached without any issues.The seat upholstery appeared to be in slightly used condition with minimal signs of wear and tear.The frame itself had a few minor scratches and dents present which are likely to be caused by impact.All four wheels were covered with a small amount of dirt grime and hair.All of the adjustment knobs were tight and secure.Based on the condition of the rollator, the type of maintenance that has been performed on the unit could not be determined.Upon further investigation of the sample, it was discovered that the right rear wheel had a slight wobble to it, and that a grinding noise could be physically heard as well.The evidence provided with the physical sample leads to the bearing being defective.At the time the sample was being reviewed, no metal shavings were observed.It is possible that the ball bearing retainer ring fell out, and then the customer stepped on it.A potential root cause of this issue is most likely due to the age of the unit, and the lack of maintenance performed.Due to the reported need for medical treatment, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a rollator wheel was locking up and shedding metal shavings.

• Type of Device: ROLLATOR,STEEL,KNOCK-DOWN
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12497524
• MDR Text Key: 272232773
• Report Number: 1417592-2021-00173
• 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
• Report Date: 09/20/2021

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850ESKD
• Device Lot Number: 88517090006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 64