MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SURG N95 RESP,FLAT-FOLD,TWIST,GREEN

Catalog Number	NON27501
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the straps have snapped out of the mask.The customer was contacted and requested to provide additional information, the photo was reviewed, the trending was reviewed, and after the complaint was reopened due to receiving samples, the samples were inspected.The samples were inspected and 14 of the non27501 had one of the straps torn from the side of the mask; based on the results of the investigation the issue is confirmed.Medline was unable to identify the root cause of the issue or the responsible party, the unaffected samples met product specifications, and the investigation indicated no need for further action 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.
Event or Problem Description
It was reported that "the straps have snapped out of the mask.".

• Brand Name: MEDLINE
• Common Device Name: SURG N95 RESP,FLAT-FOLD,TWIST,GREEN
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitsh sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50914788
• Report Number: 1417592-2026-51925
• Device Sequence Number: 12110812
• Product Code: MSH
• UDI-Device Identifier: 10080196721719
• UDI-Public: 10080196721719
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K092824
• 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: NON27501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/12/2025
• 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: 02/25/2025
• Initial Report FDA Received Date: 09/28/2026
• 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