MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MATTRESS,SYSTEM,SUPRA DPS,LAL/ALT. P

Catalog Number	MDT24SUPRADPS
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a "deflating mattress" and "the pumping tube has a line of tiny punctures that could not be sourced.".
Additional Manufacturer Narrative
The customer reported they were notified by supervisor to examine a deflating mattress, the resident¿s back was touching the bedframe, and the pumping tube has a line of tiny punctures that could not be sourced.Medline was provided the mattress and pump for evaluation and noticed that there was black tape wrapped around the air hose due to possible air leakage.The issue was confirmed from the sample provided; however, due to the time the mattress has been in use, medline was unable to determine a root cause, and can't confirm that this is not customer use/missuse.The results of the investigation indicate no need for further action.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: DBD-MATTRESS,SYSTEM,SUPRA DPS,LAL/ALT. P
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50889523
• Report Number: 1417592-2026-50526
• Device Sequence Number: 21509040
• Product Code: FNM
• UDI-Device Identifier: 40080196372196
• UDI-Public: 40080196372196
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K933965
• 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: MDT24SUPRADPS
• Device Lot Number: 90324030005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2025
• 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: 05/19/2025
• Initial Report FDA Received Date: 09/24/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown