CASE SOIL INDICATOR CSI001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for CASE SOIL INDICATOR CSI001 manufactured by Case Medical Inc..

MAUDE Entry Details

Report NumberMW5087311
MDR Report Key8695878
Date Received2019-06-12
Date of Report2019-06-10
Date of Event2019-05-14
Date Added to Maude2019-06-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCASE SOIL INDICATOR
Generic NameINDICATOR, PHYSICAL / CHEMICAL STERILIZATION PROCESS
Product CodeJOJ
Date Received2019-06-12
Returned To Mfg2019-05-10
Model NumberCSI001
Lot Number1274070
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCASE MEDICAL INC.
Manufacturer AddressSOUTH HACKENSACK NJ 07606 US 07606


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-12

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