MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-03 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Mallinckrodt Manufacturing Llc..
| Report Number | 3004531588-2019-00108 |
| MDR Report Key | 9150709 |
| Date Received | 2019-10-03 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-05-31 |
| Date Mfgr Received | 2019-09-03 |
| Device Manufacturer Date | 2017-09-22 |
| Date Added to Maude | 2019-10-03 |
| 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 | MS. MEGAN VERNAK |
| Manufacturer Street | 1425 US ROUTE 206 |
| Manufacturer City | BEDMINSTER NJ 07921 |
| Manufacturer Country | US |
| Manufacturer Postal | 07921 |
| Manufacturer Phone | 9082386455 |
| 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 | 0 |
| Brand Name | INOMAX DSIR (DELIVERY SYSTEM) |
| Generic Name | APPARATUS |
| Product Code | MRN |
| Date Received | 2019-10-03 |
| Returned To Mfg | 2019-08-16 |
| Model Number | 10007 |
| 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 | 6603 FEMRITE DRIVE MADISON WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-03 |