FDA Adverse Event
Injury
Summary report: N
SKYTRON
MDR report key: 7734559
·
Received July 31, 2018
Report
- Report Number
- 3006437518-2015-00003
- Event Type
- Injury
- Date Received
- July 31, 2018
- Report Date
- May 29, 2020
- Manufacturer
- DAI-ICHI SHOMEI CO., LTD
- Product Code
- FSY
- PMA / PMN Number
- K002463
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON APRIL 16, 2015, DAI-ICHI SHOMEI RECEIVED INFORMATION THAT THE SURGICAL LIGHT CAUSED A BURN INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 579537 | SKYTRON | SURGICAL LIGHT | FSY | DAI-ICHI SHOMEI CO., LTD | ST2323 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |