MAUDE Adverse Event Report: Hologic, Inc. Tomcat Instrument; STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Model Number	COMMON
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• Brand Name: Tomcat Instrument
• Common Device Name: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE
• Manufacturer (Section D): Hologic, Inc.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): Hologic, Inc.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: zachary hansen ; 10210 genetic center drive; san diego, CA 92121 ; +1(951)973-9240
• MDR Report Key: 50301936
• Report Number: 2024800-2026-00063
• Device Sequence Number: 13433972
• Product Code: JQW
• UDI-Device Identifier: 15420045504677
• UDI-Public: 15420045504677
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Model Number: COMMON
• Device Catalogue Number: ASY-07379
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown