MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-20 for OVU-QUICK ONE-STEP * manufactured by Quidel Corp.
[330795]
One of the physicians (ob-gyn) stated that two pts had non-operational ovuquick one-step not work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029922 |
| MDR Report Key | 492779 |
| Date Received | 2003-10-20 |
| Date of Report | 2003-10-20 |
| Date Added to Maude | 2003-11-03 |
| 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 | 3 |
| 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 | OVU-QUICK ONE-STEP |
| Generic Name | OVULATION PREDICTOR |
| Product Code | NGE |
| Date Received | 2003-10-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 481480 |
| Manufacturer | QUIDEL CORP |
| Manufacturer Address | * SAN DIEGO CA 92121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-10-20 |