MAUDE Adverse Event Report: Medivators Inc DEFENDO Air/Water and Suction Valves

Model Number	100306
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury

• Brand Name: DEFENDO Air/Water and Suction Valves
• Common Device Name: DEFENDO Air/Water and Suction Valve
• Manufacturer (Section D): Medivators Inc; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): Medivators Inc; 3150 pollok drive; conroe TX 77303
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50721489
• Report Number: 1651395-2026-00018
• Device Sequence Number: 10367362
• Product Code: ODC
• UDI-Device Identifier: 00724995246730
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100306
• Device Catalogue Number: 100306
• Device Lot Number: (10)678822
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/10/2026
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown