MAUDE Adverse Event Report: CLINICAL INNOVATIONS KIWI OMNICUP; KIWI OMNICUP VACUUM DELIVERY SYSTEM WITH TRACTION FORCE INDICATOR

Model Number	VAC-6000MTE
Health Effect - Clinical Code	Cephalohematoma (2599)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will be returned for evaluation.A supplemental will be submitted when new information or updates are received.
Event or Problem Description
A report has been received reporting the following: kiwi dislodged.Lost suction.Cephalhaematoma.Baby to nicu.It was reported that another clinical innovations kiwi was used successfully.We are in the process of gathering additional information.

• Brand Name: KIWI OMNICUP
• Common Device Name: KIWI OMNICUP VACUUM DELIVERY SYSTEM WITH TRACTION FORCE INDICATOR
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• MDR Report Key: 8834204
• Report Number: 1722684-2019-00015
• Device Sequence Number: 14141953
• Product Code: HDB
• UDI-Device Identifier: 00814247020659
• UDI-Public: 00814247020659
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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-6000MTE
• Device Lot Number: 181231
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other