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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chemical Exposure (2570)

Event Date 05/01/2015

Event Type  malfunction  

Manufacturer Narrative

The user facility contacted chemtrec for advice and medical assistance.Chemtrec contacted the rocky mountain poison and drug center for immediate medical assistance.The prolystica 2x concentrate enzymatic presoak and cleaner label clearly states, "warning: contains subtilisins (proteolytic enzyme)(cas#9014-01-1).Irritating to eyes and skin.Prolonged or frequently repeated contact to substilisins may cause allergic reaction in some individuals.Wear protective eyewear and gloves." steris made multiple attempts to obtain additional information, however the user facility will not respond.

Event Description

The user facility reported that a patient suffered eye exposure to prolystica 2x enzymatic presoak and cleaner.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 4847546
• MDR Text Key: 219220050
• Report Number: 1937531-2015-00005
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: No
• 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