FDA.reportPublic FDA data

MAUDE MDR 7911955

MDR report key
7911955
Report number
1937531-2018-00002
Event key
0
Event type
3
Date of event
2018-08-29
Date received
2018-09-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. DANIEL DAVY
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 HP NEUTRAL MANUAL CLEANERCLEANERSTERIS CORPORATIONFLG294085N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-260

Event Narratives#

N

Patient 1

THE LOT HISTORY RECORD (LHR) FOR PROLYSTICA HP MANUAL CLEANER WAS REVIEWED AND NO ABNORMALITIES WERE NOTED. THE MANUAL CLEANER'S SAFETY DATA SHEET STATES (PAGE 4; SECTION 11)," TOXICOLOGICAL INFORMATION, SYMPTOMS/INJURIES AFTER SKIN CONTACT MAY CAUSE IRRITATION". PROLYSTICA HP NEUTRAL MANUAL CLEANER IS NON-TOXIC AND NOT CONSIDERED HAZARDOUS. A STERIS ACCOUNT MANAGER STATED THAT THE CUSTOMER IS A NEW USER OF PROLYSTICA HP MANUAL CLEANER. THE CUSTOMER HAS DECIDED TO REPLACE THE MANUAL CLEANER WITH A NEW STERIS DETERGENT. THIS IS THE FIRST COMPLAINT OF IRRITATION EVER RECEIVED BY STERIS FOR THE PRODUCT SUBJECT OF THE EVENT AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

D

Patient 1

THE USER FACILITY REPORTED THAT EMPLOYEES EXPERIENCED LIGHT THROAT IRRITATION WHILE HANDLING PROLYSTICA HP NEUTRAL MANUAL CLEANER. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.