MAUDE Adverse Event Report: Clinical Innovations, LLC Kiwi Vacuum Delivery System, OmniCup; Kiwi OmniCup

Model Number	VAC-6000ME
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury

• Brand Name: Kiwi Vacuum Delivery System, OmniCup
• Common Device Name: Kiwi OmniCup
• Manufacturer (Section D): Clinical Innovations, LLC; 747 west 4150 south; murray UT 84123
• Manufacturer (Section G): Clinical Innovations, LLC; 747 west 4150 south; murray UT 84123
• Manufacturer Contact: thomas hirte ; 747 west 4150 south; murray, UT 84123
• MDR Report Key: 50923231
• Report Number: 1722684-2026-00021
• Device Sequence Number: 14952203
• Product Code: HDB
• UDI-Device Identifier: 00814247020635
• UDI-Public: 00814247020635
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K981260
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: VAC-6000ME
• Device Lot Number: 260712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2026
• 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