MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-28 for BARD DAVOL * manufactured by C.r. Bard, Inc..
[17770528]
Describe event or problem: bulb split.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019212 |
| MDR Report Key | 284114 |
| Date Received | 2000-06-28 |
| Date of Report | 2000-06-19 |
| Date of Event | 2000-06-15 |
| Date Added to Maude | 2000-07-05 |
| 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 |
| 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 | BARD DAVOL |
| Generic Name | EAR AND ULCER SYRINGE |
| Product Code | KCP |
| Date Received | 2000-06-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 0005270, REORDER NO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 274946 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30209 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-06-28 |