MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for WALGREENS EARLY RESULT ANALOG PREGNANCY TEST manufactured by Unknown.
[140774947]
I took the (b)(6) early result analog pregnancy test on two separate occasions and was shocked to see one faint and one dark line. Per the instructions contained in the test box, this indicates a positive test result. After contacting my doctor and confirming that i am not pregnant, i looked at the reviews on the (b)(6) website. This appears to be a chronic problem and users have experienced a positive test result when testing with water. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085481 |
| MDR Report Key | 8471301 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-25 |
| Date Added to Maude | 2019-04-01 |
| 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 | WALGREENS EARLY RESULT ANALOG PREGNANCY TEST |
| Generic Name | KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER |
| Product Code | LCX |
| Date Received | 2019-03-29 |
| Lot Number | 1902254 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Brand Name | WALGREENS EARLY RESULT ANALOG PREGNANCY TEST |
| Generic Name | KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER |
| Product Code | LCX |
| Date Received | 2019-03-29 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-29 |