FDA.reportPublic FDA data

MAUDE MDR 4576465

MDR report key
4576465
Report number
1937531-2015-00003
Event key
0
Event type
3
Date of event
2015-02-06
Date received
2015-03-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. KATHRYN CADORETTE
Address
5960 HEISLEY ROAD MENTOR OH 44060 US
Phone
440-440-4403
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANERCLEANERSTERIS CORPORATIONFLG*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-0601. O

Event Narratives#

N

Patient 1

A STERIS ACCOUNT MANAGER ARRIVED ONSITE AND FOUND PERSONNEL TO BE USING THE PRODUCT IN A TEMPORARY WORK SPACE. THE ACCOUNT MANAGER PERFORMED IN-SERVICE TRAINING ON DOSING AND PROPER USE OF THE PRODUCT IN THE TEMPORARY WORK SPACE AS PERSONNEL DO NOT HAVE ACCESS TO AN ACU-SINK IN THIS ROOM. IN ADDITION, THE ACCOUNT MANAGER DISCUSSED THE IMPORTANCE OF PROPER PPE. PERSONNEL WHO HANDLE PROLYSTICA STATED THEY THEIR ARMS GET WET WHILE CLEANING. CLEANING WITH THIS PRODUCT IS PERFORMED BY A THIRD PARTY REPROCESSING COMPANY THAT WORKS ON-SITE. THE USER FACILITY STATED THAT THEY ARE UNABLE TO PROVIDE ADDITIONAL INVESTIGATION INFORMATION SPECIFICALLY WHETHER MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED. THE USER FACILITY STATED THEY WILL CONTACT THE THIRD PARTY REPROCESSING COMPANY IN REGARDS TO THE REPORTED EVENT. THE PROLYSTICA PRODUCT LABEL STATES: "WARNING- IRRITATING TO EYES AND SKIN. PROLONGED OR FREQUENTLY REPEATED CONTACT TO SUBTILISINS MAY CAUSE ALLERGIC REACTION IN SOME INDIVIDUALS." "DO NOT GET IN EYES, ON SKIN OR ON CLOTHING. WEAR PROTECTIVE EYEWEAR AND GLOVES."

D

Patient 1

THE USER FACILITY REPORTED THAT STAFF MEMBERS ARE DEVELOPING RASHES AFTER CONTACT WITH PROLYSTICA.