MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2001-10-09 for PERCUPUMP CT INJECTOR WITH EDA 7805 manufactured by E-z-em, Inc..
[21387541]
It was reported that the injector flow rate was set for 2. 5 cc/sec with a total injection volume of 150 ml. After injecting approximately 120 cc's of contrast, the patient advised the technician of "tightness or pressure" in the arm. The technician stopped the injection and it was estimated that approximately 25 cc's of contrast extravasated under and near the edges of the eda patch. Patient was treated with ice packs and arm elevated. Symptoms began to dissipate after about 20 minutes without further medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432460-2001-00019 |
| MDR Report Key | 357160 |
| Report Source | 05,06,07 |
| Date Received | 2001-10-09 |
| Date of Report | 2001-09-10 |
| Date of Event | 2001-09-08 |
| Date Facility Aware | 2001-09-08 |
| Report Date | 2001-09-10 |
| Date Reported to Mfgr | 2001-09-10 |
| Date Mfgr Received | 2001-09-10 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2001-10-24 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH MERITZ, VP |
| 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 | PERCUPUMP CT INJECTOR WITH EDA |
| Generic Name | CT INJECTOR W/EXTRAVASATION ACCESSORY |
| Product Code | FIH |
| Date Received | 2001-10-09 |
| Model Number | NA |
| Catalog Number | 7805 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | 29 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 346381 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 113-117 MAGNOLIA 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 | 2 | 1. Other | 2001-10-09 |