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

Catalog Number	WRX449724
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/08/2023
Type of Reportable Event	Death
Event or Problem Description
According to the customer on (b)(6) 2023 her father "was walking with the rollator to the bathroom and turned the device around to sit stationary by the sink".Per the customer her father "sat down" on the stationary device, but was unable to confirm if the brakes were applied when sitting.Per the customer when her father sat down "the back left leg snapped just below the weld by the cross bar, throwing them back and hitting their head on the bathroom tub".
Additional Manufacturer Narrative
According to the customer on (b)(6) 2023 her father "was walking with the rollator to the bathroom and turned the device around to sit stationary by the sink".Per the customer her father "sat down" on the stationary device, but was unable to confirm if the brakes were applied when sitting.Per the customer when her father sat down "the back left leg snapped just below the weld by the cross bar, throwing them back and hitting their head on the bathroom tub".Per the customer her father was "alert" and emergency services were called.Per the customer her father was taken to the emergency room where imaging was taken which confirmed "no head injury, but revealed 2 snapped vertebrae".Per the customer her father was transferred to another facility for surgery, but was "unable to recover from the procedure and passed on (b)(6) 2023".Per the customer the device was purchased from walgreens approximately 4 years ago and is available for evaluation.The sample was requested for evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: ROLLATOR,SUPER LIGHT,250LB CAP.
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17683107
• Report Number: 1417592-2023-00360
• Device Sequence Number: 17712504
• Product Code: ITJ
• UDI-Device Identifier: 00311917124711
• UDI-Public: 00311917124711
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2023

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
• Device Lot Number: 88515120056
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male
• Patient Weight: 73 KG