MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for FIRST RESPONSE EARLY RESULT PREGNANCY TEST manufactured by Church & Dwight Co.,inc..
[39484375]
False positive pregnancy test on every single first response early result test that i've taken the last six months, at least 9 of them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060632 |
| MDR Report Key | 5471108 |
| Date Received | 2016-02-26 |
| Date of Report | 2016-02-26 |
| Date of Event | 2016-02-26 |
| Date Added to Maude | 2016-03-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FIRST RESPONSE EARLY RESULT PREGNANCY TEST |
| Generic Name | FIRST RESPONSE EARLY RESULT PREGNANCY TEST |
| Product Code | LCX |
| Date Received | 2016-02-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHURCH & DWIGHT CO.,INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-26 |