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

Catalog Number	WRX449724
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the right front wheel of the rollator broke off the device as the end-user was eating and turning away from her refrigerator.The end-user experienced a fall onto her kitchen floor.She was taken to a local hospital's emergency department (ed).No ed diagnostic exams/results were reported to the manufacturer.The end-user stated that she was diagnosed with aspiration pneumonia and was admitted to the hospital for one week and was then admitted to a rehabilitation facility for twenty days.No admitting diagnoses for the rehabilitation facility was reported to the manufacturer.When the end-user was discharged from the rehabilitation facility, she followed up with her physician.Reportedly, the physician performed unidentified x-ray exams and the end-user was diagnosed with a right thumb fracture.No medical treatments related to the diagnosed right thumb fracture was reported to the manufacturer.According to the end-user she is currently receiving home health care from a nurse, however, the diagnose which lead to the need for home health care was not identified.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported admissions and the right thumb fracture, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a rollator wheel broke off the device and the end-user experienced a fall.

• Common Device Name: ROLLATOR,SUPER LIGHT,250LB CAP
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8784780
• Report Number: 1417592-2019-00114
• Device Sequence Number: 1690021
• Product Code: ITJ
• UDI-Device Identifier: 10311917124718
• UDI-Public: 10311917124718
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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: WRX449724
• Device Lot Number: 88516120037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/12/2019
• 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: Hospitalization; Disability
• Patient Age: 62 YR
• Patient Weight: 180