INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-13 for INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS manufactured by Nanosonics Limited.

MAUDE Entry Details

Report Number9026006
MDR Report Key9026006
Date Received2019-09-13
Date of Report2019-03-08
Date of Event2018-03-28
Report Date2019-03-08
Date Reported to FDA2019-03-08
Date Reported to Mfgr2019-09-13
Date Added to Maude2019-09-13
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

Generic NameINDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
Product CodeJOJ
Date Received2019-09-13
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNANOSONICS LIMITED
Manufacturer Address2500 BEE CAVE ROAD BLDG 1, SUITE 300 AUSTIN TX 78746 US 78746


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-13

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