MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-10-10 for VOLDYNE2500 VOLUMETRIC EXERCISER 8884719025 manufactured by Teleflex Medical.
Report Number | 3003898360-2019-01197 |
MDR Report Key | 9176173 |
Report Source | COMPANY REPRESENTATIVE,USER F |
Date Received | 2019-10-10 |
Date of Report | 2019-09-23 |
Date of Event | 2019-09-23 |
Date Mfgr Received | 2019-09-23 |
Date Added to Maude | 2019-10-10 |
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 | RANCHO EL DESCANSO |
Manufacturer City | TECATE 21478 |
Manufacturer Country | MX |
Manufacturer Postal Code | 21478 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VOLDYNE2500 VOLUMETRIC EXERCISER |
Generic Name | SPIROMETER, THERAPEUTIC (INCEN |
Product Code | BWF |
Date Received | 2019-10-10 |
Catalog Number | 8884719025 |
Lot Number | UNKNOWN |
Device Availability | Y |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TELEFLEX MEDICAL |
Manufacturer Address | MORRISVILLE NC |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-10-10 |