MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR

Catalog Number	WRX449724
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the customer was walking to the bathroom at approximately 6am and on the bathroom floor when the front right wheel of the rollator broke off, the customer fell to the floor hit his head on the bathroom cabinets and broke the three small toes on his left foot.The customer's family member stated that the fall was unwitnessed, the customer has a known history of parkinson's disease and they do not know if the device broke and the customer fell or if the customer fell on the device resulting in the device breaking.The family member purchased the rollator from (b)(6) approximately one year ago, the customer uses the device daily and has not had issues with the device since the purchase.The customer was taken to the emergency room by family members where the customer was evaluated.X-rays were performed which confirmed the diagnosis of the fractured toes.The emergency room physician taped the three small toes and referred the customer to a podiatrist for follow up care.No additional injuries were noted by the emergency room physician.The customer's family reported that no additional medical intervention or follow up medical care was obtained by the customer related to the broken toes.The sample was returned for evaluation and the broken wheel appears to be the result of external impact to the device.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the rollator's front right wheel broke resulting in the end-user falling and fracturing the three toes on the left foot.

• Common Device Name: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8453248
• Report Number: 1417592-2019-00036
• Device Sequence Number: 3219090
• Product Code: ITJ
• UDI-Device Identifier: 10311917124718
• UDI-Public: 10311917124718
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/26/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: WRX449724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/26/2019
• 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: Other
• Patient Age: 75 YR
• Patient Weight: 93