MAUDE Adverse Event Report: Centurion- TRI-STATE DE MEXICO, S. DE R.L DE C.V. Medline; EBSI SENSITIVE SKIN VAD KIT

Catalog Number	EBSI1502
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Codes	Skin Inflammation/ Irritation (4545); Dry Skin (4839)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury

• Brand Name: Medline
• Common Device Name: EBSI SENSITIVE SKIN VAD KIT
• Manufacturer (Section D): Centurion- TRI-STATE DE MEXICO, S. DE R.L DE C.V.; calz. pte. v. carranza #301; desarrollo industrial colorado; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50457951
• Report Number: 3004519921-2026-00072
• Device Sequence Number: 18702483
• Product Code: OXQ
• UDI-Device Identifier: 10193489111705
• UDI-Public: 10193489111705
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: EBSI1502
• Device Lot Number: 2026022490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male