MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-03 for FROSTBITE 3803100 manufactured by Advent Health.
| Report Number | 1419341-2019-00004 |
| MDR Report Key | 8957915 |
| Date Received | 2019-09-03 |
| Date of Report | 2019-09-03 |
| Date of Event | 2019-08-05 |
| Date Mfgr Received | 2019-08-05 |
| Device Manufacturer Date | 2019-06-12 |
| Date Added to Maude | 2019-09-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS HEATHER JENSEN |
| Manufacturer Street | 5205 US HIGHWAY 12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal | 60071 |
| Manufacturer Phone | 8156782000 |
| Manufacturer G1 | LEICA BIOSYSTEMS RICHMOND |
| Manufacturer Street | 5205 US HIGHWAY 12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FROSTBITE |
| Generic Name | FROSTBITE |
| Product Code | LEA |
| Date Received | 2019-09-03 |
| Model Number | 3803100 |
| Lot Number | 061221 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVENT HEALTH |
| Manufacturer Address | 601 EAST ROLLINS STREET ORLANDO IL 32803 US 32803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-03 |