MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-23 for AERONOX 2.0 731-9159 IP33 manufactured by International Biomedical Ltd..
Report Number | MW5089979 |
MDR Report Key | 9106492 |
Date Received | 2019-09-23 |
Date of Report | 2019-09-19 |
Date of Event | 2019-09-04 |
Date Added to Maude | 2019-09-23 |
Event Key | 0 |
Report Source Code | Voluntary 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 | 0 |
Brand Name | AERONOX 2.0 |
Generic Name | APPARATUS, NITRIC OXIDE |
Product Code | MRN |
Date Received | 2019-09-23 |
Model Number | 731-9159 IP33 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INTERNATIONAL BIOMEDICAL LTD. |
Manufacturer Address | AUSTIN TX US |
Brand Name | AERONOX 2.0 |
Generic Name | APPARATUS, NITRIC OXIDE |
Product Code | MRN |
Date Received | 2019-09-23 |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 2 |
Device Event Key | 0 |
Manufacturer | INTERNATIONAL BIOMEDICAL LTD. |
Brand Name | AERONOX 2.0 |
Generic Name | APPARATUS, NITRIC OXIDE |
Product Code | MRN |
Date Received | 2019-09-23 |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 3 |
Device Event Key | 0 |
Manufacturer | INTERNATIONAL BIOMEDICAL LTD. |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-09-23 |