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

Device Problem Insufficient Information (3190)

Patient Problem Irritation (1941)

Event Date 03/27/2014

Event Type  No Answer Provided  

Event Description

The user facility reported an employee experienced eye irritation while using prolystica 2x enzymatic presoak and cleaner.The employee did not seek medical treatment in response to the irritation.No injuries or procedural delays/cancellations were reported in association to the event.

Manufacturer Narrative

The employee who experienced the eye irritation in the reported event was not wearing any ppe during the time of the exposure.The prolystica 2x enzymatic presoak and cleaner product label states, "contains subtilisins (proteolytic enzyme).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.Do not breathe spray mist".A steris account manager discussed the importance of wearing the appropriate ppe during the use of prolystica 2x enzymatic presoak and cleaner.The steris account manager visited the facility following the event and confirmed the facility is now using the appropriate ppe.No further issues have been reported.

• Brand Name: PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANER
• Type of Device: PRESOAK AND 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: 3773663
• MDR Text Key: 4437117
• Report Number: 1937531-2014-00003
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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