MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-08 for PORTEX TUBE SECUREMENT ENDOTRACHEAL 100/503/200 manufactured by Smiths Medical Asd, Inc.
Report Number | 3012307300-2019-03828 |
MDR Report Key | 8876323 |
Date Received | 2019-08-08 |
Date of Report | 2019-08-08 |
Date of Event | 2019-07-15 |
Date Mfgr Received | 2019-07-22 |
Device Manufacturer Date | 2019-05-13 |
Date Added to Maude | 2019-08-08 |
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 | PHARMACIST |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | DAVE HALVERSON |
Manufacturer Street | 6000 NATHAN LANE NORTH |
Manufacturer City | MINNEAPOLIS MN 55442 |
Manufacturer Country | US |
Manufacturer Postal | 55442 |
Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD |
Manufacturer Street | BOUNDARY ROAD |
Manufacturer City | HYTHE, |
Manufacturer Country | UK |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | PORTEX TUBE SECUREMENT ENDOTRACHEAL |
Generic Name | SUPPORT, BREATHING TUBE |
Product Code | JAY |
Date Received | 2019-08-08 |
Catalog Number | 100/503/200 |
Lot Number | 022825 |
Device Expiration Date | 2004-04-23 |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SMITHS MEDICAL ASD, INC |
Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-08-08 |