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

Catalog Number	MDS6800BA
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the rail broke off on (b)(6) 2023" and "this bar being so weak, it bent in several places.".
Additional Manufacturer Narrative
The customer reported that her husband was sleeping, turned over to the bar assist, and "the thing just gave up and he ended on the floor"; she also reported that the bar was "so weak, it bent in several places," her husband did not get injured, no medical attention was necessary, and the device was thrown in the trash.The investigation noted that the product is subject to recall, a health hazard evaluation and fmea were referenced, no sample was available, and no further investigation will be conducted at this time.The reported problem was unconfirmed because the sample was no longer available, and the cause was listed as "unconfirmed see investigation summary." there has been no change to the reportability decision associated with this complaint, and if a sample, photo, and/or additional information becomes available, the complaint will be reopened to be further investigated.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: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945623
• Report Number: 1417592-2026-54114
• Device Sequence Number: 21215932
• Product Code: QTC
• UDI-Device Identifier: 00884389102865
• UDI-Public: 00884389102865
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 09/28/2026

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: 01/09/2025
• Initial Report FDA Received Date: 09/30/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown