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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 12/10/1998
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Patient was set up for a bi-phasic injection. The first and second phase was set for 75ml at 2. 0cc/sec. The injection site was the right antecubital vein. At 50cc of the first phase, they stopped the injection because swelling was noted at the injection site. The eda patch did not detect the extravasation. No scan of the arm was performed; however, the facility feels that all 50 cc's of contrast extravasated. The patient was treated with cold compresses and released home. A follow-up call was made the following day. The patient stated that the pain and swelling were subsiding.

 
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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 Key200149
MDR Report Key206183
Event Key193572
Report Number2432460-1999-00003
Device Sequence Number1
Product CodeFIH
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/11/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/1999
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 Date12/10/1998
Device Age13 mo
Event Location Hospital
Date Report TO Manufacturer12/11/1998
Date Manufacturer Received12/11/1998
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/1997
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: 04/20/1999 Patient Sequence Number: 1
#TreatmentTreatment Date
1,OPTIRAY 320 NON-IONIC CONTRAST MANUFACTURED BY,
2,MALLINCKRODT, 20 GAUGE ANGIOCATH BY BECTON,
3,DICKENSON.,

Database last updated on January 30, 2009

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