MAUDE Adverse Event Report: Tri-State DE Mexico, S. DE R.L. DE C.V Medline; COMPARTMENT PRESS. MONITORING KIT

Catalog Number	CMPSN001AH
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: COMPARTMENT PRESS. MONITORING KIT
• Manufacturer (Section D): Tri-State DE Mexico, S. DE R.L. DE C.V; calzada presidente venustiano; mexicali, baja california 21383 ; MX 21383
• Manufacturer Contact: martin posada ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50309172
• Report Number: 3004519921-2026-00059
• Device Sequence Number: 10687936
• Product Code: OEZ
• UDI-Device Identifier: 10653160341222
• UDI-Public: 10653160341222
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: CMPSN001AH
• Device Lot Number: 2025072290
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown