MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-20 for FLOTEC INGAGE REGULATOR 010-6000-475 DE8233-7403PD manufactured by Flotec.
[137143400]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[137143401]
When medics removed the device from the supply tank, they reported a quick flame or spark. There was no harm to the user. The event was reported to flotec. In response to this event (b)(4) and complaint (b)(4) were generated. Flotec staff did not follow established reportability procedures. It was determined that this event was non-reportable. Current staff reviewed the reports and determined them to be reportable. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832475-2019-00002 |
| MDR Report Key | 8355315 |
| Date Received | 2019-02-20 |
| Date of Report | 2019-02-20 |
| Date of Event | 2014-12-02 |
| Date Facility Aware | 2014-12-02 |
| Date Mfgr Received | 2014-12-02 |
| Device Manufacturer Date | 2009-05-05 |
| Date Added to Maude | 2019-02-20 |
| 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. BRIAN DAVIDSON |
| Manufacturer Street | 7625 WEST NEW YORK ST |
| Manufacturer City | INDIANAPOLIS IN 46214 |
| Manufacturer Country | US |
| Manufacturer Postal | 46214 |
| Manufacturer Phone | 3172736960 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLOTEC INGAGE REGULATOR |
| Generic Name | REGULATOR |
| Product Code | CAN |
| Date Received | 2019-02-20 |
| Model Number | 010-6000-475 |
| Catalog Number | DE8233-7403PD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FLOTEC |
| Manufacturer Address | 7625 WEST NEW YORK STREET INDIANAPOLIS IN 46214 US 46214 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-20 |