MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for RELI BFN18G101 manufactured by Micsafe Medical Group (china) Co. Inc..
Report Number | 1058382-2019-00007 |
MDR Report Key | 9547460 |
Date Received | 2020-01-03 |
Date of Report | 2020-01-03 |
Date of Event | 2019-12-12 |
Date Facility Aware | 2019-12-20 |
Report Date | 2020-01-03 |
Date Reported to FDA | 2020-01-03 |
Date Reported to Mfgr | 2019-12-20 |
Date Added to Maude | 2020-01-03 |
Event Key | 0 |
Report Source Code | Distributor report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RELI |
Generic Name | BLUNT FILL NEEDLE |
Product Code | GAA |
Date Received | 2020-01-03 |
Catalog Number | BFN18G101 |
Lot Number | UNK |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MICSAFE MEDICAL GROUP (CHINA) CO. INC. |
Manufacturer Address | 802-805, BUILDING 6 NO.1678 JINGSHAJIANG RD. SHANGHAI, 200333 CH 200333 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-01-03 |