MAUDE Adverse Event Report: C2Dx, Inc. Salivary Duct Dilator Set; Dilator, Catheter

Catalog Number	SDDS-18-20-HC
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction

• Brand Name: Salivary Duct Dilator Set
• Common Device Name: Dilator, Catheter
• Manufacturer (Section D): C2Dx, Inc.; 555 e eliza st; suite a; schoolcraft MI 49087
• Manufacturer (Section G): C2Dx, Inc.; 555 e eliza st; suite a; schoolcraft MI 49087
• Manufacturer Contact: izzy seraphim ; 555 e eliza st; suite a; schoolcraft, MI 49087 ; +1(888)902-2239
• MDR Report Key: 50861497
• Report Number: 3015489752-2026-00002
• Device Sequence Number: 9953177
• Product Code: GCC
• UDI-Device Identifier: 00850007350338
• UDI-Public: 00850007350338
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: SDDS-18-20-HC
• Device Lot Number: C000090
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown