MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-06 for SUNMED 9-0212-70 manufactured by Meditec Devices.
| Report Number | 3006389770-2019-00001 |
| MDR Report Key | 9284065 |
| Date Received | 2019-11-06 |
| Date of Report | 2019-10-15 |
| Date of Event | 2019-09-10 |
| Date Mfgr Received | 2019-10-14 |
| Device Manufacturer Date | 2018-05-02 |
| Date Added to Maude | 2019-11-06 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SAJJAN PAUL |
| Manufacturer Street | 2A MITUL INDUSTRIAL ESTATE SATIVALI RD, VASAI EAST |
| Manufacturer City | PALGHAR, MAHARASHTRA 401404 |
| Manufacturer Country | IN |
| Manufacturer Postal | 401404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNMED |
| Generic Name | ET INTRODUCER 9-0212-70 |
| Product Code | BSR |
| Date Received | 2019-11-06 |
| Model Number | 9-0212-70 |
| Lot Number | MD 163 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDITEC DEVICES |
| Manufacturer Address | 2A MITUL INDUSTRIAL ESTATE VASAI EAST PALGHAR, MAHARASHTRA 401404 IN 401404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-06 |