MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-20 for BABYBEAT manufactured by Nicolet Vascular, Inc..
[146557]
Add'l info rec'd from mfr 11/8/99: co has experienced no field failures with this rroduct so there isn't any failure analysis to report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002549 |
| MDR Report Key | 234749 |
| Date Received | 1999-07-20 |
| Date of Report | 1999-07-15 |
| Date Added to Maude | 1999-08-09 |
| 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 | UNKNOWN |
| 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 | BABYBEAT |
| Generic Name | DOPPLER ULTRASOUND |
| Product Code | LXE |
| Date Received | 1999-07-20 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 227499 |
| Manufacturer | NICOLET VASCULAR, INC. |
| Manufacturer Address | 6355 JOYCE DR. GOLDEN CO 80403 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-07-20 |