DISPOSABLE TRANSDUCER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-02 for DISPOSABLE TRANSDUCER manufactured by Icu Medical, Inc.

MAUDE Entry Details

Report Number8752484
MDR Report Key8752484
Date Received2019-07-02
Date of Report2019-06-10
Date of Event2019-05-14
Report Date2019-06-10
Date Reported to FDA2019-06-10
Date Reported to Mfgr2019-07-02
Date Added to Maude2019-07-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDISPOSABLE TRANSDUCER
Generic NameTRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Product CodeDRS
Date Received2019-07-02
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerICU MEDICAL, INC
Manufacturer Address4455 ATHERTON DR. SALT LAKE CITY UT 84123 US 84123


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.