MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-27 for OSOM BVBLUE TEST KIT 183 manufactured by Sekisui Diagnostics.
| Report Number | 1000520007-2019-00002 |
| MDR Report Key | 9386123 |
| Report Source | CONSUMER |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2019-10-30 |
| Date Added to Maude | 2019-11-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DAVE SIMARD |
| Manufacturer Street | 1 WALL ST |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer G1 | SEKISUI DIAGNOSTICS |
| Manufacturer Street | 6659 TOP GUN ST |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSOM BVBLUE TEST KIT |
| Generic Name | VAGINAL SIALIDASE TEST KIT |
| Product Code | MXB |
| Date Received | 2019-11-27 |
| Catalog Number | 183 |
| Lot Number | B2438 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEKISUI DIAGNOSTICS |
| Manufacturer Address | 6659 TOP GUN ST SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2019-11-27 |