MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ-ELEVATING LEGREST W/PAD,F/KR WC

Catalog Number	WCAA0139
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the side broke".
Additional Manufacturer Narrative
The customer called to report that one of the legrests she ordered is locked and she cannot get it to unlock, and it was received this way.Medline received 1 pair of wheelchair elevating leg rests in used condition, and upon further investigation of the sample it was discovered that the left side elevating leg rest is stuck in the extended position; medline was able to free it with force and a tool, and small teeth in the locking cam left grooves in the adjustment rod.The investigation results were confirmed, and the result of the pic testing was functional defect.The cause was documented as cannot determine cause with received sample, and the division will monitor through quarterly trending.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBQ-ELEVATING LEGREST W/PAD,F/KR WC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50866965
• Report Number: 1417592-2026-48509
• Device Sequence Number: 13118096
• Product Code: KNN
• UDI-Device Identifier: 00197344029917
• UDI-Public: 00197344029917
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: WCAA0139
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown