MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-23 for OMNIPAQUE * manufactured by Ge Medical Systems Inc..
[20884690]
A 50 cc bottle of contrast dye was hung and cracked with the engagement of the injector and the bottle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 620508 |
| MDR Report Key | 620508 |
| Date Received | 2005-06-23 |
| Date of Report | 2005-06-23 |
| Date of Event | 2005-06-14 |
| Report Date | 2005-06-23 |
| Date Reported to FDA | 2005-06-23 |
| Date Added to Maude | 2005-07-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIPAQUE |
| Generic Name | CONTRAST DYE |
| Product Code | KTA |
| Date Received | 2005-06-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 10258494 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 610193 |
| Manufacturer | GE MEDICAL SYSTEMS INC. |
| Manufacturer Address | 3000 N. GRANDVIEW BLVD. WAUKESHA WI 53188 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-23 |