MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-19 for MSI HCG COMBO 1158-1 manufactured by Meridian Bioscience Inc..
[2145320]
Radiologist reported on (b)(6) 2011 after reading an us done on a 9 week pregnant pt, that pt had an abdominal ct done for abdominal pain on (b)(6) 2011. Urine pregnancy test was negative which meant that pt was pregnant during ct a little over a week. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020655 |
| MDR Report Key | 2100902 |
| Date Received | 2011-05-19 |
| Date of Report | 2011-05-18 |
| Date of Event | 2011-03-30 |
| Date Added to Maude | 2011-05-26 |
| 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 | MSI HCG COMBO |
| Generic Name | URINE PREGNANCY TEST KIT |
| Product Code | LCX |
| Date Received | 2011-05-19 |
| Model Number | 1158-1 |
| Lot Number | 08101566 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIDIAN BIOSCIENCE INC. |
| Manufacturer Address | 3471 RIVER HILLS DR. CINCINNATI OH 45244 US 45244 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-19 |