MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-26 for ACCEAVA * manufactured by Thermo.
[377948]
Several sticks from the package had a very faint control. Very difficult to see control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034975 |
| MDR Report Key | 584228 |
| Date Received | 2005-03-18 |
| Date of Report | 2005-03-07 |
| Date of Event | 2005-02-25 |
| Date Added to Maude | 2005-03-24 |
| 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 |
| 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 | ACCEAVA |
| Generic Name | TEST STICKS COATED W/ANTI-HCG |
| Product Code | JHJ |
| Date Received | 2005-02-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 011063 |
| ID Number | * |
| Device Expiration Date | 2005-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 574054 |
| Manufacturer | THERMO |
| Manufacturer Address | * * CO * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-18 |