MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-08 for HENRY SCHEIN ONE STEP HCG CASSETTE 6008KHI HCG HSC manufactured by Applied Biotech, Inc..
[17868238]
Healthcare professional reported problems with device whereby the device -urine- read negative for two -2- patients, but ultrasound confirmed the patients were pregnant. Patients were estimated to be 7-weeks pregnant. Patients did not receive any adverse treatments before ultrasound confirmed pregnancy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002593 |
| MDR Report Key | 864370 |
| Date Received | 2007-06-08 |
| Date of Report | 2007-06-08 |
| Date of Event | 2007-05-15 |
| Date Added to Maude | 2007-06-18 |
| 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 |
| Health Professional | 3 |
| 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 | HENRY SCHEIN ONE STEP HCG CASSETTE |
| Generic Name | HCG URINE CASSETTE |
| Product Code | JHJ |
| Date Received | 2007-06-08 |
| Model Number | 6008KHI |
| Catalog Number | HCG HSC |
| Lot Number | 94993 |
| Device Expiration Date | 2008-09-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 847788 |
| Manufacturer | APPLIED BIOTECH, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-08 |