MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-21 for RESEARCH MEDICAL INC FOM 11-018-V * manufactured by *.
[18609120]
Femoral venous cannulas cracked/broke. Possibilty of retained in patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040478 |
| MDR Report Key | 763302 |
| Date Received | 2006-09-21 |
| Date of Report | 2006-09-20 |
| Date of Event | 2006-09-11 |
| Date Added to Maude | 2006-09-25 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESEARCH MEDICAL INC |
| Generic Name | FEMORAL VENOUS CANNULA |
| Product Code | LFK |
| Date Received | 2006-09-21 |
| Model Number | FOM 11-018-V |
| Catalog Number | * |
| Lot Number | 96962 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 751197 |
| Manufacturer | * |
| Manufacturer Address | 6864 SOUTH 300 WEST MIDVALE UT 84047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-21 |