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 Limb Fracture (4518)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that in (b)(6) 2020 the customer got up in the middle of the night to go to the washroom and while he was walking with his rollator he got a cramp in his leg so he attempted to sit down on the rollator, however when he turned the rollator around to sit down the right front wheel fell off which resulted in the customer falling to the floor and hitting his left upper arm / shoulder area.The customer stated that he was able to get up but was in pain so his wife drove him to the local emergency room for evaluation.According to the customer numerous x-rays were performed and the tests showed that there was a fracture to the left arm approximately 4 inches below the shoulder.The customer stated there were no other apparent injuries however reported that he was admitted to the hospital for 5 days for observation due to dizziness and weakness from the fall and then transferred to a rehab facility for 3 weeks following the hospitalization to work on building his strength.The customer has reportedly been discharged home with no additional follow up services noted.No product information was provided.No sample was returned for evaluation.A root cause for the reported incident could not be determined.Due to the reported fracture, hospital admission and rehabilitation stay this medwatch is being filed.If additional relevant information becomes available this report will be reopened and reevaluated.

Event Description

It was reported that the right front wheel fell off and the end-user experienced a fall while using the unknown rollator.

Manufacturer Narrative

Updated: d2, d4, d9, h3, h6.A device was received on 12/10/2020 with product code mds86850eskd in used condition with heavy wear.The right front wheel was confirmed to have broken off from the frame assembly.A definitive root cause for the reported issue could not be determined at this time.There is no additional information available.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a 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: 10924252
• MDR Text Key: 218900198
• Report Number: 1417592-2020-00148
• 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
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850ESKD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 59