MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-25 for YONKER PHOTOTHERAPY YK-6000BT manufactured by Yonker Medical.
| Report Number | 3013482554-2019-00001 |
| MDR Report Key | 8826691 |
| Date Received | 2019-07-25 |
| Date of Report | 2019-08-04 |
| Date of Event | 2019-04-04 |
| Date Added to Maude | 2019-07-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. XIAO WAN |
| Manufacturer City | XUZHOU, JIANGSU |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | YONKER PHOTOTHERAPY |
| Generic Name | UV RADIATION TREATMENT SYSTEM |
| Product Code | FTC |
| Date Received | 2019-07-25 |
| Model Number | YK-6000BT |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YONKER MEDICAL |
| Manufacturer Address | XUZHOU, 221000 CH 221000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-25 |