MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MASK,LOOP,PINK-STRIPED,FOAM,LVL 3

Catalog Number	NON27712EL
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the metal strip under the foam strip has been coming off.I compared it to an older one and yes, the foam peels off a lot easier where i can see the metal strip coming off.".
Additional Manufacturer Narrative
The customer reported that the foam strip has been coming off and that the metal strip under the foam strip has been coming off.The samples were inspected, the contract manufacturer was sent the finished device alleged failure investigation form to perform an investigation at their facility, complaint data was analyzed, the reported lot was inspected by medline, and stock was checked at the supplying branch.The samples were reviewed and the weld holding the nose piece was opened and the strips were loose; the product did not meet specifications.The vendor determined that the weld strength was not strong enough due to a malfunction of the mask machine, and based on the investigation results, no further actions are being taken 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: MASK,LOOP,PINK-STRIPED,FOAM,LVL 3
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50927227
• Report Number: 1417592-2026-52806
• Device Sequence Number: 9734240
• Product Code: FXX
• UDI-Device Identifier: 10080196754441
• UDI-Public: 10080196754441
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K223236
• 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): 09/25/2026

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: NON27712EL
• Device Lot Number: 52124100284
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/28/2025
• 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: 03/17/2025
• Initial Report FDA Received Date: 09/29/2026
• 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