MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. CENTURION; CIRCUMCISION TRAY

Catalog Number	CIT5285
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction

• Brand Name: CENTURION
• Common Device Name: CIRCUMCISION TRAY
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center 106; parque industrial oradel; nuevo laredo, tamaulipas 88285 ; MX 88285
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25756630
• Report Number: 3004122598-2026-00046
• Device Sequence Number: 13374270
• Product Code: OHG
• UDI-Device Identifier: 10653160246824
• UDI-Public: 10653160246824
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: CIT5285
• Device Lot Number: 25LBU152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2025
• 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: 1 DA
• Patient Sex: Male
• Patient Weight: 3 KG