MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-24 for ONE STEP PREGNANCY TEST manufactured by Inverness Medical 11c.
[3946015]
I purchased a pregnancy test. It comes in a foil wrapper. I got a closed box but the foil wrapper was opened. They told me not to use it but refused to replace it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032393 |
| MDR Report Key | 3434213 |
| Date Received | 2013-10-24 |
| Date of Report | 2013-10-23 |
| Date of Event | 2013-10-23 |
| Date Added to Maude | 2013-10-31 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE STEP PREGNANCY TEST |
| Generic Name | ONE STEP PREGNANCY TEST |
| Product Code | LCX |
| Date Received | 2013-10-24 |
| Device Expiration Date | 2015-05-01 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVERNESS MEDICAL 11C |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-24 |