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 2019-09-23 for HUSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FREN 003-40F manufactured by Teleflex Medical.
Report Number | 1417411-2019-00039 |
MDR Report Key | 9106489 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-09-23 |
Date of Report | 2019-08-29 |
Date of Event | 2019-08-01 |
Date Mfgr Received | 2019-08-29 |
Device Manufacturer Date | 2019-02-28 |
Date Added to Maude | 2019-09-23 |
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 | VICTORIA SANDLIN |
Manufacturer Street | 3015 CARRINGTON MILL BLVD |
Manufacturer City | MORRISVILLE NC 27560 |
Manufacturer Country | US |
Manufacturer Postal | 27560 |
Manufacturer G1 | TELEFLEX MEDICAL |
Manufacturer Street | 900 WEST UNIVERSITY DR. |
Manufacturer City | ARLINGTON HEIGHTS IL 60004 |
Manufacturer Country | US |
Manufacturer Postal Code | 60004 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | HUSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FREN |
Generic Name | HUMIDIFIER NEBULIZER KIT |
Product Code | OGG |
Date Received | 2019-09-23 |
Catalog Number | 003-40F |
Lot Number | 19B103 |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TELEFLEX MEDICAL |
Manufacturer Address | RESEARCH TRIANGLE PARK NC |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-09-23 |