MAUDE Adverse Event Report: ST PAUL CLEO; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Defective Device (2588)

Patient Problem Reaction, Injection Site (2442)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

It was reported that the subject was having multiple injection site reactions on his skin, and it was red and irritated.It was also reported that there was one site leaking fluid.The patient was seen by a dermatologist and was prescribed medication.

• Brand Name: CLEO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; building ap16-1; minneapolis, MN 55442
• MDR Report Key: 10952287
• MDR Text Key: 220412513
• Report Number: 3012307300-2020-12149
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention