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 2020-03-31 for HENRY SCHEIN MONO TEST DEVICE 20T IMO-402 manufactured by Alere San Diego.
| Report Number | 2027969-2020-00017 |
| MDR Report Key | 9908585 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-25 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 8052506 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN MONO TEST DEVICE 20T |
| Generic Name | MONONUCLEOSIS REAGENT TEST KIT |
| Product Code | KTN |
| Date Received | 2020-03-31 |
| Model Number | IMO-402 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO |
| Manufacturer Address | 9975 SUMMERS RIDGE RD SAN DIEGO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-31 |