MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-01 for HCG URINE STRIP manufactured by Wondfo.
[5683463]
Many fertility patients, including myself a physician used home pregnancy tests to check the beta-hcg levels in their systems. This can include following a hcg trigger injection or trying to determine if they are indeed pregnant. The company wondfo sells relatively inexpensive tests to consumers for quick, easy and supposedly accurate results. This test is labeled as having a sensitivity of 25miu/ml. I have had positive tests from this company all week long. Today, i decided to get my hcg blood level checked and my results were 1. 76miu/ml. I have tested positive with the wondfo pregnancy test 3 times today at levels
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041883 |
| MDR Report Key | 4664709 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-04-01 |
| Date of Event | 2015-04-01 |
| Date Added to Maude | 2015-04-08 |
| 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 | HCG URINE STRIP |
| Generic Name | URINE TEST SYSTEM |
| Product Code | LCX |
| Date Received | 2015-04-01 |
| Lot Number | W00130943-4 |
| Device Expiration Date | 2015-09-16 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WONDFO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-01 |