MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-11-30 for PERCUPUMP 2 W/EDA 7830 manufactured by E-z-em, Inc..
[199139]
Pt present for a ct scan of abdomin/pelvis. Received injection of 150cc's of contrast dye via power injector. 150cc of dye entered tissues of pt's arm. Compresses applied in er.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2432460-2000-00040 |
MDR Report Key | 308224 |
Report Source | 05,06 |
Date Received | 2000-11-30 |
Date of Report | 2000-11-29 |
Date of Event | 2000-10-24 |
Date Facility Aware | 2000-10-24 |
Report Date | 2000-11-29 |
Date Reported to Mfgr | 2000-11-07 |
Date Added to Maude | 2000-12-13 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Reporter Occupation | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | PETER APRILE, R.PH. |
Manufacturer Street | 717 MAIN STREET |
Manufacturer City | WESTBURY NY 11590 |
Manufacturer Country | US |
Manufacturer Postal | 11590 |
Manufacturer Phone | 8005444624 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Remedial Action | PM |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PERCUPUMP 2 W/EDA |
Generic Name | POWER INJECTOR |
Product Code | FIH |
Date Received | 2000-11-30 |
Model Number | NA |
Catalog Number | 7830 |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 298206 |
Manufacturer | E-Z-EM, INC. |
Manufacturer Address | 750 SUMMA AVE WESTBURY NY 11590 US |
Baseline Brand Name | PERCUPUMP TOUCHSCREEN INJECTOR SYSTEM W/EDA |
Baseline Generic Name | POWER INJECTOR |
Baseline Model No | NA |
Baseline Catalog No | 7830 |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2000-11-30 |