FDA.reportPublic FDA data

MAUDE MDR 6354585

MDR report key
6354585
Report number
1937531-2017-00004
Event key
0
Event type
3
Date of event
2017-01-24
Date received
2017-02-23
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
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 CONCENTRATE ENZYMATIC PRESOAK & CLEANERPRESOAK & CLEANERSTERIS CORPORATIONFLG* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-2301. O

Event Narratives#

N

Patient 1

THE COMPLAINANT SOUGHT AND RECEIVED MEDICAL TREATMENT AT THE FACILITY'S EMERGENCY ROOM DEPARTMENT AND RETURNED TO WORK. ADDITIONAL PERSONAL PROTECTIVE EQUIPMENT MEASURES HAVE BEEN IMPLEMENTED BY THE USER FACILITY TO PREVENT RECURRENCE. THE INDIVIDUAL IS STILL CURRENTLY WORKING WITH THE PROLYSTICA 2X CONCENTRATE. THE PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER LABEL STATES, "MAY CAUSE ALLERGY OR ASTHMA SYMPTOMS OR BREATHING DIFFICULTIES IF INHALED. IF INHALED: REMOVE PERSON TO FRESH AIR AND KEEP COMFORTABLE FOR BREATHING". THE SAFETY DATA SHEET STATES, "SYMPTOMS/INJURIES AFTER INHALATION: INHALATION OF VAPORS OR SPRAY/MISTS MAY CAUSE ALLERGY OR ASTHMA SYMPTOMS OR BREATHING DIFFICULTIES. MAY CAUSE RESPIRATORY IRRITATION". THE SAFETY DATA SHEET ALSO STATES, "PRECAUTIONS FOR SAFE HANDLING: PROVIDE GOOD VENTILATION IN PROCESS AREA TO PREVENT FORMATION OF VAPOR". NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

D

Patient 1

THE COMPLAINANT REPORTED SHORTNESS OF BREATH AFTER USING THE PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER.