MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBQ-BAR,BED ASSIST

Catalog Number	MDS6800BA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Back pain (4895)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when her husband tried to get up from bed, he grabbed himself from the bed assist and it broke and he fell to the floor.".
Additional Manufacturer Narrative
Per customer's wife, when her husband tried to get up from bed, he grabbed himself from the bed assist and it broke and he fell to the floor; he hurt his back more, was very sick prior to his fall, and passed away in (b)(6) 2022.No sample was available, and the investigation noted that this product was subject to recall and that no further investigation will be conducted at this time.The reported problem was unconfirmed.Due diligence was completed, no additional details were available, there was no confirmed medical intervention or serious injury reported related to this incident, and there was no evidence that the death occurred as a result of this incident.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-BAR,BED ASSIST
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50854017
• Report Number: 1417592-2026-47429
• Device Sequence Number: 10025878
• Product Code: MMC
• UDI-Device Identifier: 00884389102865
• UDI-Public: 00884389102865
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/21/2026

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: MDS6800BA
• Was Device Available for Evaluation?: No
• 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: 09/12/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown