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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL-FLARSHEIM INJ. OPTIV DH, W/OEM

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LIEBEL-FLARSHEIM INJ. OPTIV DH, W/OEM Back to Search Results
Model Number 844007
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Pain (1994)
Event Date 03/15/2018
Event Type  malfunction  
Event Description
The contrast was injected, the psi "was fine", "there was no contrast enhancement inside the images". "the contrast was injected into her tissue and not into her veins" they were using opti-ray contrast. They stated the customer had some pain put a cold pack in the area.
 
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Brand NameINJ. OPTIV DH, W/OEM
Type of DeviceINJ. OPTIV DH, W/OEM
Manufacturer (Section D)
LIEBEL-FLARSHEIM
2111 e. galbraith rd
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e. galbraith rd
MDR Report Key7421640
MDR Text Key105419765
Report Number1518293-2018-00010
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date 04/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number844007
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/31/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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