MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-11 for INOVENT, NITRIC OXIDE DELIVERY SYSTEM 1605-9200-000 manufactured by Mallinckrodt Manufacturing Llc..
Report Number | 3004531588-2020-00028 |
MDR Report Key | 9821381 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-03-11 |
Date of Report | 2020-03-11 |
Date of Event | 2019-12-14 |
Date Mfgr Received | 2019-12-14 |
Device Manufacturer Date | 2006-02-10 |
Date Added to Maude | 2020-03-11 |
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 | MEGAN VERNAK |
Manufacturer Street | 1425 US ROUTE 206 |
Manufacturer City | BEDMINSTER NJ 07921 |
Manufacturer Country | US |
Manufacturer Postal | 07921 |
Manufacturer G1 | MALLINCKRODT MANUFACTURING LLC. |
Manufacturer Street | 6603 FEMRITE DRIVE |
Manufacturer City | MADISON WI 53718 |
Manufacturer Country | US |
Manufacturer Postal Code | 53718 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | INOVENT, NITRIC OXIDE DELIVERY SYSTEM |
Generic Name | APPRATUS, NITRIC OXIDE DELIVERY |
Product Code | MRN |
Date Received | 2020-03-11 |
Returned To Mfg | 2019-12-26 |
Model Number | 1605-9200-000 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MALLINCKRODT MANUFACTURING LLC. |
Manufacturer Address | MADISON WI US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-03-11 |