MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-03 for VERIFY SIXCESS INDICATOR manufactured by Albert Browne Ltd..
| Report Number | 8021896-2020-00001 |
| MDR Report Key | 9548666 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date Mfgr Received | 2019-12-04 |
| Date Added to Maude | 2020-01-03 |
| 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 | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | ALBERT BROWNE LTD. |
| Manufacturer Street | CHANCERY HOUSE 190 WATERSIDE HAMILTON INDUSTRIAL PARK |
| Manufacturer City | LEICESTER, LE5 1QZ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LE5 1QZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERIFY SIXCESS INDICATOR |
| Generic Name | VERIFY SIXCESS INDICATOR |
| Product Code | JOJ |
| Date Received | 2020-01-03 |
| Lot Number | 030901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALBERT BROWNE LTD. |
| Manufacturer Address | CHANCERY HOUSE190 WATERSIDE RD HAMILTON INDUSTRIAL PARK LEICESTER, LE5 1QZ UK LE5 1QZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |