HANKS BALANCED SALT SOLUTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-04 for HANKS BALANCED SALT SOLUTION manufactured by Corning Cellgro/mediatech.

Event Text Entries

[71888945] Rare fungus seen on pathology results for 4 patients cryptococcus adeliensis. Literature search revealed that this fungus can be seen as contaminant in hanks solution which was used in all 4 biopsies. Therapy start date: (b)(6) 2017. Therapy end date: (b)(6) 2017. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5068887
MDR Report Key6459750
Date Received2017-04-04
Date of Report2017-04-03
Date of Event2017-01-06
Date Added to Maude2017-04-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHANKS BALANCED SALT SOLUTION
Generic NameHANKS BALANCED SALT SOLUTION
Product CodeKIP
Date Received2017-04-04
Lot Number23315002
Device Expiration Date2018-10-01
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCORNING CELLGRO/MEDIATECH


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-04-04

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