MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-11 for J-TIP manufactured by National Medical Products, Inc..
Report Number | 8686578 |
MDR Report Key | 8686578 |
Date Received | 2019-06-11 |
Date of Report | 2019-04-01 |
Date of Event | 2019-03-05 |
Report Date | 2019-04-01 |
Date Reported to FDA | 2019-04-01 |
Date Reported to Mfgr | 2019-06-11 |
Date Added to Maude | 2019-06-11 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | RISK MANAGER |
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 | J-TIP |
Generic Name | INJECTOR, FLUID, NON-ELECTRICALLY POWERED |
Product Code | KZE |
Date Received | 2019-06-11 |
Lot Number | 190224-040 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | NATIONAL MEDICAL PRODUCTS, INC. |
Manufacturer Address | 57 PARKER ST. IRVINE CA 92618 US 92618 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-06-11 |