MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-22 for EARLY PREGNANCY TEST manufactured by Unk.
[70989888]
I brought (b)(6) health early pregnancy test and when i attempted to use the product it didn't work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068671 |
| MDR Report Key | 6435916 |
| Date Received | 2017-03-22 |
| Date of Report | 2017-03-22 |
| Date of Event | 2017-02-01 |
| Date Added to Maude | 2017-03-27 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EARLY PREGNANCY TEST |
| Generic Name | PREGNANCY TEST |
| Product Code | LCX |
| Date Received | 2017-03-22 |
| Device Expiration Date | 2019-01-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-22 |