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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH MEDICAL USA, INC. ULRICH POWER INJECTOR INJECTOR, CONTRAST MEDIUM, AUTOMATIC

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ULRICH MEDICAL USA, INC. ULRICH POWER INJECTOR INJECTOR, CONTRAST MEDIUM, AUTOMATIC Back to Search Results
Lot Number M0190501
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/25/2020
Event Type  malfunction  
Event Description
Emergency room ct ulrich power injector 24hour internal pump tubing ruptured/leaked, no harm to patient. Fda safety report id #: (b)(4).
 
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Brand NameULRICH POWER INJECTOR
Type of DeviceINJECTOR, CONTRAST MEDIUM, AUTOMATIC
Manufacturer (Section D)
ULRICH MEDICAL USA, INC.
MDR Report Key10104976
MDR Text Key194045575
Report NumberMW5094761
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberM0190501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/29/2020 Patient Sequence Number: 1
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