MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-06 for EZEM PERCUPUMP CONTROL NI 7805 manufactured by E-z-em, Inc..
[15480338]
Pt experienced 78ml extravasation of opti 320 into left antecubial space. Existing iv site was a 22 gauge. Flow rate was 1. 7 ml/sec. The extravasation patch was in place but did not activate during injection. Pilot film was taken post-extravasation to reveal contrast in tissue. Radiologist was consulted and pt was discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432460-2000-00036 |
| MDR Report Key | 304152 |
| Date Received | 2000-11-06 |
| Date of Report | 2000-11-06 |
| Date of Event | 2000-09-20 |
| Date Facility Aware | 2000-09-20 |
| Report Date | 2000-11-06 |
| Date Reported to Mfgr | 2000-10-05 |
| Date Mfgr Received | 2000-10-05 |
| Date Added to Maude | 2000-11-14 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZEM PERCUPUMP CONTROL |
| Generic Name | POWER INJECTOR |
| Product Code | FIH |
| Date Received | 2000-11-06 |
| Model Number | NI |
| Catalog Number | 7805 |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 294340 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 750 SUMMA AVE. WESTBURY NY 11590 US |
| Baseline Brand Name | PERCUPUMP TOUCHSCREEN INJECTOR W/EDA |
| Baseline Generic Name | CT INJECTOR SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 7805 |
| Baseline ID | NA |
| Baseline Device Family | PERCUPUMP INJECTOR SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K961845 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-11-06 |