MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-02-12 for SKYTRON ST23 manufactured by Dkk.
[16987490]
(b)(6) hospital contacted distributor questioning lights causing 2nd degree burns. The operating room was shut down until the service technician could evaluate. The uv filters were not installed on the lights and may have contributed to burns on patient's dating back to (b)(6) 2014. The facility has been trained on the use of the uv filters but has since removed lights from their facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825014-2014-00021 |
| MDR Report Key | 4534105 |
| Report Source | 99 |
| Date Received | 2015-02-12 |
| Date of Report | 2015-02-11 |
| Date of Event | 2014-11-24 |
| Date Facility Aware | 2014-01-12 |
| Report Date | 2015-11-02 |
| Date Reported to FDA | 2015-12-02 |
| Date Reported to Mfgr | 2015-12-02 |
| Date Added to Maude | 2015-02-24 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | SURGICAL LIGHTS |
| Product Code | EBA |
| Date Received | 2015-02-12 |
| Model Number | ST23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DKK |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-02-12 |