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

MAUDE Adverse Event Report: LIEBEL-FLARSHEIM COMPANY LLC INJECTOR, CONTRAST MEDIUM, AUTOMATIC

  • 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
 

LIEBEL-FLARSHEIM COMPANY LLC INJECTOR, CONTRAST MEDIUM, AUTOMATIC Back to Search Results
Lot Number P259A
Device Problem No Display/Image (1183)
Patient Problem Insufficient Information (4580)
Event Date 10/15/2021
Event Type  malfunction  
Event Description
Injection of 20 ml of dotarem® in right arm using a power injector (lot number p259a). No contrast showed up on images.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceINJECTOR, CONTRAST MEDIUM, AUTOMATIC
Manufacturer (Section D)
LIEBEL-FLARSHEIM COMPANY LLC
2111 e. galbraith road
cincinnati OH 45237
MDR Report Key13839966
MDR Text Key287541167
Report Number13839966
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot NumberP259A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/01/2022
Date Report to Manufacturer03/21/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-