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

Catalog Number	MDS6800BA
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i got in trap"[ped inside of this rail and almost smothered in my sleep.".
Additional Manufacturer Narrative
The customer stated that "i got in trapped inside of this rail and almost smothered in my sleep," and it was reported that the user rolled over in bed and "got stuck in bed rail"; no medical intervention, serious injury, or follow-up care has been reported.Medline received one bed assist bar in used condition, unassembled, and upon assembly, all parts secured properly with the push buttons and c-clips; the unit was dirty and used, no defects were found, the mattress strap was not received, and it is unknown if the customer had the mattress strap installed.The complaint was unconfirmed because no defects were found, and the cause was documented as unconfirmed/see investigation.The product is subject to recall, and the division will monitor through 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-BAR,BED ASSIST
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946803
• Report Number: 1417592-2026-54340
• Device Sequence Number: 16039408
• Product Code: QTC
• UDI-Device Identifier: 00884389102865
• UDI-Public: 00884389102865
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/29/2026

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: MDS6800BA
• Device Lot Number: 88519080006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/01/2025
• 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: 06/30/2025
• Initial Report FDA Received Date: 09/30/2026
• 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