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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CLEO; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7220-24
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Cellulitis (1768)
Event Date 09/05/2020
Event Type  Injury  
Event Description
It was reported that a patient reported mild redness of study drug previous infusion site on abdomen in the morning that became more red and tender.Patient was seen by a doctor who diagnosed cellulitis.No further adverse patient effects were reported.
 
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Brand Name
CLEO
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11090368
MDR Text Key224248483
Report Number3012307300-2020-12826
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586028335
UDI-Public10610586028335
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/19/2023
Device Model Number21-7220-24
Device Catalogue Number21-7220-24
Device Lot Number3676602
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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