MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-08-26 for 3GA ALWAYS OPEN INROOM -CLEAR 85221 manufactured by Covidien.
| Report Number | 1424643-2019-00542 |
| MDR Report Key | 8930872 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-08-26 |
| Date of Report | 2019-08-26 |
| Date of Event | 2019-08-15 |
| Date Mfgr Received | 2019-08-15 |
| Date Added to Maude | 2019-08-26 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 815 TEK DRIVE |
| Manufacturer City | CRYSTAL LAKE IL 600399002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600399002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3GA ALWAYS OPEN INROOM -CLEAR |
| Generic Name | CONTAINER, SHARPS |
| Product Code | MMK |
| Date Received | 2019-08-26 |
| Model Number | 85221 |
| Catalog Number | 85221 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 815 TEK DRIVE CRYSTAL LAKE IL 600399002 US 600399002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-26 |