MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-29 for ANGIOSCOPE (DISPOSABLE) * manufactured by Edwards Life Science.
[373489]
White "paint" (depth markings) flaked off scope during use. All pieces were flushed out of vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035049 |
| MDR Report Key | 586710 |
| Date Received | 2005-03-29 |
| Date of Report | 2005-03-29 |
| Date of Event | 2005-03-03 |
| Date Added to Maude | 2005-04-01 |
| 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 |
| 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 | ANGIOSCOPE (DISPOSABLE) |
| Generic Name | * |
| Product Code | LYK |
| Date Received | 2005-03-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | JM3F0961 |
| ID Number | * |
| Device Expiration Date | 2006-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 576558 |
| Manufacturer | EDWARDS LIFE SCIENCE |
| Manufacturer Address | * IRVINE CA 926145866 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-29 |