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 2019-06-19 for HENRY SCHEIN STREP A DIPSTICK 25T IST-511 1074050 manufactured by Alere San Diego, Inc..
| Report Number | 2027969-2019-00117 |
| MDR Report Key | 8712123 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-06-19 |
| Date of Report | 2019-09-10 |
| Date of Event | 2019-01-13 |
| Date Mfgr Received | 2019-09-09 |
| Date Added to Maude | 2019-06-19 |
| 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 | HENRY SCHEIN STREP A DIPSTICK 25T |
| Generic Name | STREP A TEST |
| Product Code | GTY |
| Date Received | 2019-06-19 |
| Returned To Mfg | 2019-06-28 |
| Model Number | IST-511 |
| Catalog Number | 1074050 |
| Lot Number | STA8100003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-19 |