MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-13 for HCG ONE STEP PREGNANCY TEST DEVICE (URINE) FHC-102 manufactured by Alere San Diego.
| Report Number | 2027969-2019-00600 |
| MDR Report Key | 9319102 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-13 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-09-06 |
| Date Mfgr Received | 2019-10-29 |
| Date Added to Maude | 2019-11-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HCG ONE STEP PREGNANCY TEST DEVICE (URINE) |
| Generic Name | HCG PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2019-11-13 |
| Model Number | FHC-102 |
| Lot Number | HCG9010123 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO |
| Manufacturer Address | 9995 SUMMERS RIDGE RD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-13 |