MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-14 for FLOTEC manufactured by .
| Report Number | 1832475-2019-00004 |
| MDR Report Key | 8608998 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2007-05-24 |
| Date Added to Maude | 2019-05-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN PICHON |
| Manufacturer Street | 7625 WEST NEW YORK STREET |
| Manufacturer City | INDIANAPOLIS IN 462144911 |
| Manufacturer Country | US |
| Manufacturer Postal | 462144911 |
| Manufacturer Phone | 3172736960 |
| Manufacturer G1 | FLOTEC |
| Manufacturer Street | 7625 WEST NEW YORK STREET |
| Manufacturer City | INDIANAPOLIS IN 462144911 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 462144911 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOTEC |
| Generic Name | FLOPAC |
| Product Code | CAN |
| Date Received | 2019-05-14 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |