MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-25 for HTG CASING 46-239746G26 * manufactured by G.e. Medical Systems.
[353983]
During a cardiac catheterization, a pressure hose that is part of the c-arm tube caught on a protective shield, pulled loose, spraying the pt and staff with an oil identified as diala oil m. No adverse pt or staff outcomes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031656 |
| MDR Report Key | 519938 |
| Date Received | 2004-03-25 |
| Date of Report | 2004-03-10 |
| Date of Event | 2004-02-22 |
| Date Added to Maude | 2004-04-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HTG CASING |
| Generic Name | X-RAY TUBE |
| Product Code | ITY |
| Date Received | 2004-03-25 |
| Model Number | 46-239746G26 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 509019 |
| Manufacturer | G.E. MEDICAL SYSTEMS |
| Manufacturer Address | P.O. BOX 402076 ATLANTA GA 303842076 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-03-25 |