MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; WC,EXCEL,18",PERM ARM,SA, 300 LB

Catalog Number	MDS806150D
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "the frame is bent, which is causing the front wheels to rub together and affecting proper function".There were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.
Event or Problem Description
It was reported that the the frame is bent, which is causing the front wheels to rub together and affecting proper function.

• Brand Name: MEDLINE
• Common Device Name: WC,EXCEL,18",PERM ARM,SA, 300 LB
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: mohammed haider ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25340414
• Report Number: 1417592-2026-01834
• Device Sequence Number: 10002538
• Product Code: IOR
• UDI-Device Identifier: 00080196718675
• UDI-Public: 00080196718675
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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?: Yes
• Device Catalogue Number: MDS806150D
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2025
• 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
• Patient Sex: Unknown