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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

Following the reported event, the user facility contacted steris.Steris immediately provided the user facility with the safety data sheet for prolystica 2x presoak and cleaner.During the time of the reported event, the employee was wearing short gloves while utilizing the cleaning product allowing the cleaning product to seep into their gloves and cause the reported event.The prolystica 2x presoak and cleaner safety data sheet states (pg.3), "protective equipment, wear protective gloves, and eye/face protection.Avoid all unnecessary exposure.Personal protective equipment should be selected based upon the conditions under which this product is handled or used.Protective clothing, gloves, protective googles." steris offered in-service training on the proper use of prolystica 2x presoak and cleaner and the user facility has declined this offer.Steris has made multiple attempts to contact the user facility for additional details on the employee's condition, however a response has not been received.No additional issues have been reported.

Event Description

The user facility reported that an employee utilized prolystica 2x presoak and cleaner and experienced a reaction on their hands as a result.The employee sought medical treatment at a dermatology practice.

• Brand Name: PROLYSTICA 2X CONCENTRATE 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7429315
• MDR Text Key: 105774191
• Report Number: 1937531-2018-00001
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2018
• 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