MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-07-10 for BARD EAR & ULCER SYRINGE * manufactured by C.r. Bard, Inc..
[167443]
Defective ear and ulcer syringe. Split after few uses where the two halves of the bulb are glued together. This was the 4th syringe returned this way from various other pts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019284 |
| MDR Report Key | 285638 |
| Date Received | 2000-07-10 |
| Date of Report | 2000-07-10 |
| Date of Event | 2000-03-08 |
| Date Added to Maude | 2000-07-17 |
| 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 | PHARMACIST |
| 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 EAR & ULCER SYRINGE |
| Generic Name | EAR & ULCER SYRINGE |
| Product Code | KCP |
| Date Received | 2000-07-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 276419 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 730 CENTRAL AVE MURRAY HILL NJ 07974 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-07-10 |