MAUDE Adverse Event Report: Medline Industries, LP Medline; MATTRESS,SYSTEM,A10,LAL/ALTERNATING

Catalog Number	MDT24A10
Medical Device Problem Codes	Deflation Problem (1149); Unintended Deflation (4061)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Peripheral Edema (4578)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that beginning on (b)(6) 2026 the "air mattress is not holding air and it leaks out slowly over a few hours of time." according to the customer, "the patient had a small pressure wound which has since been slowly increasing in size" due to the lack of "pressure relief needed from the air mattress.".
Additional Manufacturer Narrative
It was reported that beginning on (b)(6) 2026 the "air mattress is not holding air and it leaks out slowly over a few hours of time." according to the customer, "the patient had a small pressure wound which has since been slowly increasing in size" due to the lack of "pressure relief needed from the air mattress." per the customer, the individual has begun sleeping in their wheelchair resulting in lower extremity edema and fluid "leaking out of his legs." the customer stated that the individual's "condition continues to deteriorate." it has been determined that though the event did not involve a death or serious injury, recurrence could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Medline
• Common Device Name: MATTRESS,SYSTEM,A10,LAL/ALTERNATING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50804269
• Report Number: 1417592-2026-10082
• Device Sequence Number: 8644256
• Product Code: FNM
• UDI-Device Identifier: 10193489135671
• UDI-Public: 10193489135671
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: n/a
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDT24A10
• Device Lot Number: 240530
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 255 LB