MAUDE Adverse Event Report: CLINICAL INNOVATIONS LLC KIWI VACUUM DELIVERY SYSTEM; EXTRACTOR, VACUUM, FETAL

Model Number	VAC-6000MT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abrasion (1689)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have reached out to obtain additional information for this event.If any additional information is provided, a follow-up report may be submitted.
Event or Problem Description
Abrasions were made on the adsorption area (head) of the child.

• Brand Name: KIWI VACUUM DELIVERY SYSTEM
• Common Device Name: EXTRACTOR, VACUUM, FETAL
• Manufacturer (Section D): CLINICAL INNOVATIONS LLC; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: thomas hirte ; 747 w 4170 s; murray, UT 84123 ; 8012688200
• MDR Report Key: 20612225
• Report Number: 1722684-2024-00013
• Device Sequence Number: 20868967
• Product Code: HDB
• UDI-Device Identifier: 00814247020642
• UDI-Public: 00814247020642
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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
• Device Model Number: VAC-6000MT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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