MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BED, SEMI ELECTRIC, MEDLITE

Catalog Number	MDR107002L
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the frame of the bed has been cracked.".
Additional Manufacturer Narrative
The customer stated, "the frame of the bed has been cracked," and the complaint transcript noted "no injuries or falls indicated." the investigation documented "sample and/or photo provided? not available," pcn history was reviewed and "no product changes were identified that could've contributed to this product failure," and quality control inspections records were reviewed with inspection records passing per the inspection reports.The investigation results were "not confirmed" because no sample or photo of the defective product was received, therefore the issue could not be confirmed at that time.The conclusion was that a formal investigation will be conducted should the sample arrive, or if a detailed photo is provided, 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: BED, SEMI ELECTRIC, MEDLITE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: madelyn ruppert ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931460
• Report Number: 1417592-2026-52883
• Device Sequence Number: 13143074
• Product Code: LLI
• UDI-Device Identifier: 40080196294320
• UDI-Public: 40080196294320
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: MDR107002L
• Was Device Available for Evaluation?: Yes
• 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: 06/02/2023
• Initial Report FDA Received Date: 09/29/2026
• 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