MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-04 for CODE BLUE EASY-LAV * 1534 manufactured by Ballard Medical Products.
[147390]
During lavage of stomach content, the red plunger pulled contents from the container, instead of pt's stomach.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017847 |
| MDR Report Key | 257391 |
| Date Received | 2000-01-04 |
| Date of Report | 1999-12-27 |
| Date of Event | 1999-11-15 |
| Date Added to Maude | 2000-01-06 |
| 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 | 0 |
| 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 | CODE BLUE EASY-LAV |
| Generic Name | GASTRIC LAVAGE SYSTEM |
| Product Code | KDH |
| Date Received | 2000-01-04 |
| Model Number | * |
| Catalog Number | 1534 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 249250 |
| Manufacturer | BALLARD MEDICAL PRODUCTS |
| Manufacturer Address | 12050 LONE PEAK PKWY DRAPER UT 84020 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-01-04 |