MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MATTRESS,SYSTEM,MEDTECH,TRUE LAL,36X80

Catalog Number	MDT24MEDAIR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿we¿ve had two air mattresses from your most recent air mattress purchase (according to my guys) from medline with holes in them.They seem to be manufactural defects since the holes are at a seam.¿.
Additional Manufacturer Narrative
The customer reported two air mattresses ¿with holes in them¿ and stated the ¿holes are at a seam.¿ review of the customer-provided photograph confirms that the mattress cover zipper separated, resulting in the cover opening and exposing the foam core; the vendor reviewed the complaint and confirmed the issue, determining that the product was covered under warranty.Based on the visual evidence provided, the reported complaint is confirmed.No device history record review or additional testing was performed, and a specific root cause was not identified; as a corrective action, the vendor issued a replacement cover to the customer, and the vendor further indicated that this complaint was not part of a larger trend.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,SYSTEM,MEDTECH,TRUE LAL,36X80
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50889085
• Report Number: 1417592-2026-50464
• Device Sequence Number: 9762063
• Product Code: FNM
• UDI-Device Identifier: 10080196372034
• UDI-Public: 10080196372034
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: MDT24MEDAIR
• 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: 07/10/2023
• 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