CADD ADMINISTRATION SET CADD ADMINISTRATION SETS 21-7394-24

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2019-11-29 for CADD ADMINISTRATION SET CADD ADMINISTRATION SETS 21-7394-24 manufactured by Infusystem Inc.

MAUDE Entry Details

Report Number3012307300-2019-06693
MDR Report Key9391927
Report SourceCONSUMER,HEALTH PROFESSIONAL,
Date Received2019-11-29
Date of Report2019-11-27
Date of Event2019-10-31
Date Mfgr Received2019-11-01
Device Manufacturer Date2019-05-21
Date Added to Maude2019-11-29
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 ContactDAVE HALVERSON
Manufacturer Street6000 LANE N
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone7633833310
Manufacturer G1SMITHS MEDICAL ASD,INC
Manufacturer Street6000 LANE N
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCADD ADMINISTRATION SET
Generic NameSET, ADMINISTRATION, INTRAVASCULAR
Product CodeFPA
Date Received2019-11-29
Model NumberCADD ADMINISTRATION SETS
Catalog Number21-7394-24
Lot Number3808534
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINFUSYSTEM INC
Manufacturer Address11130 STRANG LINE RD LENEXA KS 66215 US 66215


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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