MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; WHEELCHAIR,K4 LIGHT,20",DLA,S/A FOOT

Catalog Number	MDS806560
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Abdominal Pain (1685); Bone Fracture(s) (1870)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on (b)(6) 2024 "they were leaving the office building that their doctor is in and going to their car when the bolt that holds the front wheel in place snapped and sent me falling to the asphalt".Per the customer a family member and doctor helped the user into their car.Per the customer on (b)(6) 2024 they "developed severe abdominal pain" and they were brought to the hospital on (b)(6) 2024 "where it was determined via a ct scan that they had a hematoma and left femur fracture".Per the customer they "had surgery to repair the broke femur on (b)(6) 2024 and remained in the hospital until (b)(6) 2024".Per the customer they are "doing better".Per the customer the "there were no obstructions or uneven surfaces" when the incident occurred.Per the customer "both wheels were previously replaced on the item".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.
Event or Problem Description
According to the customer on (b)(6) 2024 "they were leaving the office building that their doctor is in and going to their car when the bolt that holds the front wheel in place snapped and sent me falling to the asphalt".

• Common Device Name: WHEELCHAIR,K4 LIGHT,20",DLA,S/A FOOT
• 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: 19166538
• Report Number: 1417592-2024-00534
• Device Sequence Number: 12533982
• Product Code: IOR
• UDI-Device Identifier: 10080196739592
• UDI-Public: 10080196739592
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/23/2024

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: MDS806560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 91 KG