FDA Adverse Event
Malfunction
Summary report: N
VALLEYLAB
MDR report key: 10565553
·
Received September 22, 2020
Report
- Report Number
- 1717344-2020-01092
- Event Type
- Malfunction
- Date Received
- September 22, 2020
- Date of Event
- August 24, 2020
- Report Date
- September 22, 2020
- Manufacturer
- NEW DEANTRONICS LTD
- Product Code
- GEI
- UDI-DI
- 20884521751306
- PMA / PMN Number
- K152031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEPARTMENT USING THE PRODUCT HAD A FIRE INCIDENT. THE FIRE OCCURRED WHEN THEY WERE PLUGGING IN THE ITEM. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1029905 | VALLEYLAB | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | NEW DEANTRONICS LTD | E3810 | 2001037X | 20884521751306 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |