MAUDE Adverse Event Report: TRI-STATE DE MEXICO, S. DE R.L. DE C.V MEDLINE; SUTURE REMOVAL TRAY

Catalog Number	DYNDR1278
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: SUTURE REMOVAL TRAY
• Manufacturer (Section D): TRI-STATE DE MEXICO, S. DE R.L. DE C.V; calzada presidente venustiano; carranza #301; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25772821
• Report Number: 3004519921-2026-00034
• Device Sequence Number: 10645571
• Product Code: LRP
• UDI-Device Identifier: 10653160355663
• UDI-Public: 10653160355663
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: DYNDR1278
• Device Lot Number: 2026011490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2026
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White