VOLDYNE2500 VOLUMETRIC EXERCISER 8884719025

MAUDE Adverse Event Report

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 2019-10-07 for VOLDYNE2500 VOLUMETRIC EXERCISER 8884719025 manufactured by Teleflex Medical.

MAUDE Entry Details

Report Number3003898360-2019-01180
MDR Report Key9163809
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-10-07
Date of Report2019-09-17
Date of Event2019-09-16
Date Mfgr Received2019-11-05
Date Added to Maude2019-10-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetRANCHO EL DESCANSO
Manufacturer CityTECATE 21478
Manufacturer CountryMX
Manufacturer Postal Code21478
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVOLDYNE2500 VOLUMETRIC EXERCISER
Generic NameSPIROMETER, THERAPEUTIC (INCEN
Product CodeBWF
Date Received2019-10-07
Returned To Mfg2019-10-15
Catalog Number8884719025
Lot NumberUNKNOWN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-07

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