MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MASK,FLEXIBLE,ANESTH,SIZE 5,TOP VALVE

Catalog Number	DYNJAAMASK35
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "deformed mask shape.See image below comparing the normal (oval) to the abnormal (rounded).".
Additional Manufacturer Narrative
The reported issue was "deformed mask shape," with a photo "comparing the normal (oval) to the abnormal (rounded)"; the complaint noted the issue did not occur during use and no injury occurred.A photo and sample were received for investigation; the photo showed one unit with the reported issue next to one unit in normal condition, and the physical items were received without their original packaging, with 2 ea deformed/irregular in shape and 1 ea oval shaped and normal in appearance.Medline could confirm the issue of the masks being deformed and could confirm the product failed to meet specifications.Medline was not able to confirm what may have caused the issue, and the quality team will monitor this issue for trending purposes.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: MASK,FLEXIBLE,ANESTH,SIZE 5,TOP VALVE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50946326
• Report Number: 1417592-2026-54227
• Device Sequence Number: 10446243
• Product Code: BSJ
• UDI-Device Identifier: 10888277399310
• UDI-Public: 10888277399310
• 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): 09/30/2026

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: DYNJAAMASK35
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2025
• 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: 08/28/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown