MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 02/06/2015

Event Type  No Answer Provided  

Manufacturer Narrative

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.".

Event Description

The user facility reported that staff members are developing rashes after contact with prolystica.

• Brand Name: PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANER
• Type of Device: 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4576465
• MDR Text Key: 19065450
• Report Number: 1937531-2015-00003
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 02/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other