MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-28 for PROTOCOL TOUCH ADMINISTRATION SET manufactured by Bracco Diagnostics Inc.
Report Number | 2411512-2019-00003 |
MDR Report Key | 8744408 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-06-28 |
Date of Report | 2019-07-24 |
Date of Event | 2019-06-12 |
Date Mfgr Received | 2019-06-12 |
Device Manufacturer Date | 2017-02-06 |
Date Added to Maude | 2019-06-28 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | PATRICE MARCHILDON |
Manufacturer Street | 155 PINELAWN ROAD SUITE 230N |
Manufacturer City | MELVILLE NY 11747 |
Manufacturer Country | US |
Manufacturer Postal | 11747 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PROTOCOL TOUCH ADMINISTRATION SET |
Generic Name | PROTOCOL TOUCH ADMINISTRATION SET |
Product Code | FCX |
Date Received | 2019-06-28 |
Lot Number | 9189BBE |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BRACCO DIAGNOSTICS INC |
Manufacturer Address | 155 PINELAWN RD SUITE 230 N MELVILLE NY 11747 US 11747 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2019-06-28 |