MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MATTRESS,EQAIRE PLUS 9000,35X80X7, AG

Catalog Number	MDTEP93580A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the mattress came in with a broken valve.The valve is severed.
Additional Manufacturer Narrative
The customer reported that the mattress came in with a broken valve and that the valve is severed.Medline contacted the vendor, wcw inc, and gave them the complaint information; this is a vendor product and the investigation will be done by the vendor or vendor affiliates.The complaint could not be confirmed as there were no lot/serial numbers, samples, pictures or videos received.Without a sample received, it is difficult to determine a true root cause for the reported issue; the division performs quarterly trending on all complaints received and will initiate further investigation and/or supplier corrective action requests based on trending results.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: MATTRESS,EQAIRE PLUS 9000,35X80X7, AG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50889323
• Report Number: 1417592-2026-50503
• Device Sequence Number: 15900572
• Product Code: FNM
• UDI-Device Identifier: 10193489086096
• UDI-Public: 10193489086096
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/24/2026

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: MDTEP93580A
• 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: 11/16/2023
• Initial Report FDA Received Date: 09/24/2026
• 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