• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC SHORT TERM LESS THAN 30 DAYS

  • 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
 

CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC SHORT TERM LESS THAN 30 DAYS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Complaint, Ill-Defined (2331)
Event Type  Injury  
Event Description
Pt went to emergency room (er) week ago due to issues with her catheter.No other info provided.Pt does not consent to be contacted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CATHETER
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC SHORT TERM LESS THAN 30 DAYS
MDR Report Key8532922
MDR Text Key142730128
Report NumberMW5086016
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age47 YR
Patient Weight186
-
-