MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-09-19 for WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP 820-5002-33 manufactured by Jms Singapore Pte Ltd.
| Report Number | 3002807350-2019-00007 |
| MDR Report Key | 9085649 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-09-19 |
| Date of Report | 2019-09-13 |
| Date of Event | 2019-06-19 |
| Date Facility Aware | 2019-08-19 |
| Report Date | 2019-09-13 |
| Date Reported to FDA | 2019-09-13 |
| Date Reported to Mfgr | 2019-09-13 |
| Date Mfgr Received | 2019-08-22 |
| Device Manufacturer Date | 2018-11-12 |
| Date Added to Maude | 2019-09-19 |
| 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 | MS. CHIA CHIN YIN |
| Manufacturer Street | 440 ANG MO KIO INDUSTRIAL PARK 1 |
| Manufacturer City | SINGAPORE, 569620 |
| Manufacturer Country | SN |
| Manufacturer Postal | 569620 |
| Manufacturer G1 | PT. JMS BATAM CAMMO INDUSTRIAL PARK |
| Manufacturer Street | CAMMO INDUSTRIAL PARK BLK. F, NO.2, BATAM CENTRE |
| Manufacturer City | INDONESIA, 29461 |
| Manufacturer Country | ID |
| Manufacturer Postal Code | 29461 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP |
| Generic Name | JMS WINGEATER A.V.FISTULA NEEDLE SET |
| Product Code | FIE |
| Date Received | 2019-09-19 |
| Model Number | 820-5002-33 |
| Lot Number | 181112351 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JMS SINGAPORE PTE LTD |
| Manufacturer Address | 440 ANG MO KIO INDUSTRIAL PARK 1 SINGAPORE, 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-09-19 |