MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-18 for PRECISION 400 * manufactured by Kendall.
[487825]
The nurse caring for this patient said the patient arrived in the sicu from the emergency department. It is their practice to switch out the urimeter when the patient arrives on the unit. The urimeter started to leak where the clear plastic face was molded to the white plastic backing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 726688 |
| MDR Report Key | 726688 |
| Date Received | 2006-05-18 |
| Date of Report | 2006-05-18 |
| Date of Event | 2006-05-05 |
| Report Date | 2006-05-18 |
| Date Reported to FDA | 2006-05-18 |
| Date Added to Maude | 2006-06-20 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISION 400 |
| Generic Name | URIMETER |
| Product Code | EYZ |
| Date Received | 2006-05-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 715036 |
| Manufacturer | KENDALL |
| Manufacturer Address | A DIVISION OF TYCO HEALTHCARE 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-18 |