MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MATTRESS,SYSTEM,SUPRA AIR PRO,LAL

Catalog Number	MDTSUPAIRPRO
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "after observing, the clear tape that holds the cells together rips/becomes loose that holds the cells together.Many of the air cells pop out/up high while others are very low and almost look deflated with no air flow".
Additional Manufacturer Narrative
The customer reported that patients have been complaining about the comfort of the mattress, the clear tape that holds the cells together rips/becomes loose, and many of the air cells pop out/up high while others are very low and almost look deflated with no air flow.Sample confirms complaint; however, all samples had been taped to try and fix the issue and medline was unable to take the tape off the straps without further damage to the straps.No potential cause for the issue was found within the production records, and medline could not confirm if this was customer caused.Vendor stated that exceeding maximum weight capacity may result in breakage of the fixation straps or heat exposure such as electric blankets should not be used as prolonged exposure to heat can cause material to become brittle and crack; a review of trending data indicates no negative trends associated with this defect or product code, and no further action is required at this time.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,SUPRA AIR PRO,LAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50610742
• Report Number: 1417592-2026-32230
• Device Sequence Number: 21510698
• Product Code: FNM
• UDI-Device Identifier: 10197344102273
• UDI-Public: 10197344102273
• 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): 09/02/2026

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: MDTSUPAIRPRO
• Device Lot Number: 240920
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2026
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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