MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-01-31 for NICOLET ELITE WATERPOOF 2MHZ DOPPLER PROBE X1-L006 NW20 manufactured by Nicolet Vascular.
[19154255]
Customer stated that probe was received with what appeared to be blood on the face of the probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718469-2002-00001 |
| MDR Report Key | 375152 |
| Report Source | 06 |
| Date Received | 2002-01-31 |
| Date of Report | 2002-01-22 |
| Date of Event | 2002-01-08 |
| Date Mfgr Received | 2002-01-11 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2002-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID WAGNER |
| Manufacturer Street | 6355 JOYCE DRIVE |
| Manufacturer City | GOLDEN CO 80403 |
| Manufacturer Country | US |
| Manufacturer Postal | 80403 |
| Manufacturer Phone | 3034319400 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NICOLET ELITE WATERPOOF 2MHZ DOPPLER PROBE |
| Generic Name | OB DOPPLER PROBE |
| Product Code | HEK |
| Date Received | 2002-01-31 |
| Model Number | X1-L006 |
| Catalog Number | NW20 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 364277 |
| Manufacturer | NICOLET VASCULAR |
| Manufacturer Address | 6355 JOYCE DRIVE GOLDEN CO 80403 US |
| Baseline Brand Name | NICOLET ELITE WATERPROOF PROBE |
| Baseline Generic Name | OB DOPPLER PROBE |
| Baseline Model No | X1-L006 |
| Baseline Catalog No | NW20 |
| Baseline Device Family | NICOLET ELITE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K982635 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-01-31 |