MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MATTRESS,SYSTEM,MEDTECH MAX,36X80X10

Catalog Number	MDT24MEDAIRMX
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that mattress has a bubble in the middle/off to the side.
Additional Manufacturer Narrative
The customer reported a bubble in the mattress surface and provided photographic evidence depicting the alleged condition.The complaint file, customer-provided photograph, and vendor correspondence were reviewed as part of the investigation, and the photographs were forwarded to moxi holding group llc for evaluation.Although the reported condition appears consistent with the customer description, a serial number was not available and the product was not returned for evaluation; therefore, a production record review and sample analysis could not be performed.No root cause was identified, and moxi holding group llc determined that replacement of the mattress was appropriate; a replacement mattress was subsequently provided to the customer.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 MAX,36X80X10
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947926
• Report Number: 1417592-2026-54520
• Device Sequence Number: 10446681
• Product Code: FNM
• UDI-Device Identifier: 10080196372058
• UDI-Public: 10080196372058
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: MDT24MEDAIRMX
• 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: 11/15/2024
• 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