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 |