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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA HP ENZYMATIC MANUAL CLEANER
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STERIS CORPORATION PROLYSTICA HP ENZYMATIC MANUAL CLEANER Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 03/02/2021
Event Type  malfunction  
Manufacturer Narrative
The prolystica hp enzymatic manual cleaner safety data sheet states (1), "may cause allergic skin reaction." a review of our records indicates that this product was packaged according to specifications prior to shipment.The user facility has been provided with replacement product.No additional issues have been reported.
 
Event Description
The user facility reported an employee experienced face irritation after opening a damaged box of leaking prolystica hp enzymatic manual cleaner.The employee sought medical treatment and took an antihistamine tablet.
 
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Brand Name
PROLYSTICA HP ENZYMATIC MANUAL CLEANER
Type of Device
PROLYSTICA HP ENZYMATIC MANUAL CLEANER
Manufacturer (Section D)
STERIS CORPORATION
7501 page avenue
st. louis MO 63133
Manufacturer (Section G)
STERIS CORPORATION
7501 page avenue
st. louis MO 63133
Manufacturer Contact
daniel davy
5960 heisley rd
mentor, OH 44060
4403927453
MDR Report Key11636117
MDR Text Key265145459
Report Number1937531-2021-00001
Device Sequence Number1
Product Code FLG
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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