MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-22 for FLOTEC DR813-700P4 manufactured by Flotec.
[139586379]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139586380]
Day: (b)(6) 2019. Time: prior to 2:15 est. The user reported that some type of pop, flame, or ignition occurred as operator loosened dome handle on part # dr813-700p4, serial number (b)(4), before releasing pressure in the regulator. Unknown injury report. As of march 22, 2019 there has been no response to requests to a injury report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832475-2019-00003 |
| MDR Report Key | 8444538 |
| Report Source | CONSUMER |
| Date Received | 2019-03-22 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2009-07-10 |
| Date Added to Maude | 2019-03-22 |
| 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 | JOHN PICHON |
| Manufacturer Street | 7625 WEST NEW YORK STREET |
| Manufacturer City | INDIANAPOLIS IN 46214 |
| Manufacturer Country | US |
| Manufacturer Postal | 46214 |
| Manufacturer Phone | 3172736960 |
| Manufacturer G1 | FLOTEC |
| Manufacturer Street | 7625 WEST NEW YORK STREET |
| Manufacturer City | INDIANAPOLIS IN 46214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46214 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOTEC |
| Generic Name | INGAGE REGULATOR |
| Product Code | CAN |
| Date Received | 2019-03-22 |
| Model Number | DR813-700P4 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-22 |