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Adverse Event Report

E-Z-EM, INC. PERCUPUMP TOUCHSCREEN INJECTOR SYSTEM W/EDA CT INJECTOR W/EXTRAVASATION ACCESSORY   back to search results
Catalog Number 7805
Device Problem False-negative test result
Event Date 08/11/1998
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Pt was set up for a bi-phasic study. Seventy five ml of contrast was injected into the pt's right endecubital vein. An extravasation occurred under the eda patch. There was swelling approx 4 inches long and 1-1. 5 inches high. The injector read "range ok". It was believed that all of the 75 ml of contrast extravasated into the arm. The pt complained of pain. Compresses were applied and benedryl was given. The pt was sent home and returned for follow up on 8/12/98 and appeared to be doing okay.

 
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Brand NamePERCUPUMP TOUCHSCREEN INJECTOR SYSTEM W/EDA
Type of DeviceCT INJECTOR W/EXTRAVASATION ACCESSORY
Baseline Brand NamePERCUPUMP TOUCHSCREEN INJECTOR W/EDA
Baseline Generic NameCT INJECTOR SYSTEM
Baseline Catalogue Number7805
Baseline Device FamilyPERCUPUMP INJECTOR SYSTEM
Baseline Device 510(K) NumberK961845
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/06/1998
Manufacturer (Section F)
E-Z-EM, INC.
113-117 magnolia ave.
westbury NY 11590
Manufacturer (Section D)
E-Z-EM, INC.
113-117 magnolia ave.
westbury NY 11590
Manufacturer (Section G)
E-Z-EM, INC.
717 main st.
westbury NY 11590
Manufacturer Contact
gina vogelsberg
717 main street
westbury , NY 11590
(516) 333 -8230
Device Event Key181825
MDR Report Key187057
Event Key175869
Report Number2432460-1998-00011
Device Sequence Number1
Product CodeFIH
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Other
Remedial Action Patient Monitoring
Type of Report Initial,Followup
Report Date 08/11/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7805
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/11/1998
Device Age3 mo
Event Location Hospital
Date Report TO Manufacturer08/11/1998
Date Manufacturer Received08/11/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/1998
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/16/1999 Patient Sequence Number: 1
#TreatmentTreatment Date
1,OPTIRAY (NON-IONIC) CONTRAST,

Database last updated on January 30, 2009

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