Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CADD CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NULL CADD CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Headache (1880); Nausea (1970); Pain (1994); Hot Flashes/Flushes (2153); Chills (2191)
Event Date 10/30/2021
Event Type  malfunction  
Manufacturer Narrative
Udi and catalog information are unknown.Manufacturing site address is unknown.Premarket (510k) number is unknown.Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
Per a social media search, it was reported that while on remodulin, the patient experienced headache, chills, nausea, leg or foot pain, and flushing.Patient advised that in their experience, all of those fade once you are on a stable dose for a bit.The one that sticks around is the jaw pain.
 
Manufacturer Narrative
Other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, this complaint will be reopened for further investigation.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD CLEO INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key16137200
MDR Text Key308114721
Report Number3012307300-2023-00344
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-