MAUDE Adverse Event Report: Medline Industries, LP - Namic Namic; COMP,3V,200S,RH,ON,OEM,PG

Catalog Number	80058308
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• Brand Name: Namic
• Common Device Name: COMP,3V,200S,RH,ON,OEM,PG
• Manufacturer (Section D): Medline Industries, LP - Namic; 10 glens falls; technical park drive; glens falls NY 12801 -386
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50829375
• Report Number: 3015910259-2026-00176
• Device Sequence Number: 8900825
• Product Code: DRS
• UDI-Device Identifier: 10193489066715
• UDI-Public: 10193489066715
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K902472
• 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): 09/18/2026

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: 80058308
• Device Lot Number: 0000182268
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown