MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-31 for TOPCO 87-935-000(TH1091) 87-935-000 manufactured by Shenzhen Dongdixin Technology Co., Ltd..
| Report Number | 3005170249-2019-00002 |
| MDR Report Key | 9264703 |
| Date Received | 2019-10-31 |
| Date of Report | 2019-10-01 |
| Date Mfgr Received | 2019-10-02 |
| Date Added to Maude | 2019-10-31 |
| 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 | MRS |
| Manufacturer Street | BLOCK A, 5TH FLOOR, FUHUA TECH NO. 9116 BEIHUAN ROAD |
| Manufacturer City | SHENZHEN, 518057 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518057 |
| Manufacturer G1 | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
| Manufacturer Street | NO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,NANSHAN |
| Manufacturer City | SHENZHEN, 518108 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 518108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TOPCO |
| Generic Name | INFRARED THERMOMETER |
| Product Code | FLL |
| Date Received | 2019-10-31 |
| Model Number | 87-935-000(TH1091) |
| Catalog Number | 87-935-000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
| Manufacturer Address | NO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,NANSHAN SHENZHEN, 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-10-31 |