MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-15 for CONFIRM CLEARLY 30136 * manufactured by *.
[16820970]
*confirm clearly refillable digital pregnancy test* i bought a test, and some refills to check progress to see if i had become pregnant yet. Took the first test just like it said to do. Waited, it came back positive. Ecstatic, i took another just to confirm by using a refill that came with the test. Waited... Test came back negative. Took one more, waited, negative again. Researched these tests online. Found forums full of similar situations like mine -false positives-, i think something needs to be done about this proudct before it gets out of hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041003 |
| MDR Report Key | 782403 |
| Date Received | 2006-11-15 |
| Date of Report | 2006-11-15 |
| Date of Event | 2006-11-15 |
| Date Added to Maude | 2006-11-21 |
| 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 | PATIENT |
| 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 | CONFIRM CLEARLY |
| Generic Name | DIGITAL REFILLABLE PREGNANCY TEST READER |
| Product Code | LCY |
| Date Received | 2006-11-15 |
| Model Number | 30136 |
| Catalog Number | * |
| Lot Number | L6616 |
| ID Number | * |
| Device Expiration Date | 2008-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 770201 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-15 |