MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KOALA INTRAUTERIN PRESSURE CATHETER; TRANSDUCER, PRESSURE, INTRAUTERINE

Model Number IPC-5000E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Clinical innovations is gathering additional information regarding this event.If any more information becomes available, a follow-up report will be submitted.

Event Description

The user facility reported the following: "we have been using the iupc's for a couple weeks now and have had a couple injuries to babies that are potentially related the to the insertion of the koala iupcs".

• Brand Name: KOALA INTRAUTERIN PRESSURE CATHETER
• Type of Device: TRANSDUCER, PRESSURE, INTRAUTERINE
• 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: kellie stefaniak ; 747 w 4170 s; murray, UT 84123 ; 8012688200
• MDR Report Key: 11280027
• MDR Text Key: 230458871
• Report Number: 1722684-2021-00001
• Device Sequence Number: 1
• Product Code: HFN
• UDI-Device Identifier: 00814247020178
• UDI-Public: 00814247020178
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPC-5000E
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other