MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-12-03 for CONSULT HCG URINE CASSETTE 5001 25T FHC-A102 manufactured by Alere San Diego.
| Report Number | 2027969-2019-00603 |
| MDR Report Key | 9404666 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-12-03 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-30 |
| Date Added to Maude | 2019-12-03 |
| 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 | MONIKA BURRELL |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052506 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONSULT HCG URINE CASSETTE 5001 25T |
| Generic Name | HCG PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2019-12-03 |
| Returned To Mfg | 2020-03-23 |
| Model Number | FHC-A102 |
| Lot Number | HCG9050069 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-12-03 |