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 |