MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-02-27 for MERITS HEALTH PRODUCTS CO., LTD E60421YLMUB E60411-90 manufactured by Merits Health Products Co., Ltd.
| Report Number | 9680333-2020-00001 |
| MDR Report Key | 9765465 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-11-21 |
| Date Facility Aware | 2019-11-14 |
| Report Date | 2020-02-06 |
| Date Reported to Mfgr | 2020-02-06 |
| Date Mfgr Received | 2019-11-21 |
| Device Manufacturer Date | 2018-06-15 |
| Date Added to Maude | 2020-02-27 |
| 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 | EFY CHENG |
| Manufacturer Street | NO. 18. JINGKE RD,TPMT PARK NATUN DISTRICT |
| Manufacturer City | TAICHUNG CITY, 40852 |
| Manufacturer Country | TW |
| Manufacturer Postal | 40852 |
| Manufacturer G1 | MERITS HEALTH PRODUCTS LTD |
| Manufacturer Street | NO. 18. JINGKE RD,TPMT PARK NANTUN DISTRICT |
| Manufacturer City | TAICHUNG CITY, 40852 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 40852 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERITS HEALTH PRODUCTS CO., LTD |
| Generic Name | PILOT NAVIGATOR |
| Product Code | PCD |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2019-11-22 |
| Model Number | E60421YLMUB |
| Catalog Number | E60411-90 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERITS HEALTH PRODUCTS CO., LTD |
| Manufacturer Address | NO. 18. JINGKE RD,TPMT PARK, NANTUN DISTRICT TAICHUNG CITY, 40852 TW 40852 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly | 2020-02-27 |