MAUDE Adverse Event Report: CLINICAL INNOVATIONS KOALA IUPC; INTRAUTERINE PRESSURE CATHETER

Model Number IPC-5000E

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

Clinical innovations is attempting to gather as much information as possible.If any more information becomes available, a follow up report will be submitted.

Event Description

The description below is what the user reported: since we have re-educated providers on insertion technique we are not seeing the "scraping" injuries from iupc placement.However, we have now had a few pressure injuries from just the lie of the catheter.This iupc was only in place for 3 hours.

• Brand Name: KOALA IUPC
• Type of Device: INTRAUTERINE PRESSURE CATHETER
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: kellie stefaniak ; 747 w 4170 s; murray, UT 83123 ; 8012688200
• MDR Report Key: 11734520
• MDR Text Key: 254967473
• Report Number: 1722684-2021-00004
• Device Sequence Number: 1
• Product Code: HFN
• 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: 04/27/2021

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 Operator: Health Professional
• Device Model Number: IPC-5000E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 04/27/2021
• 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