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

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

Patient Problems Headache (1880); Complaint, Ill-Defined (2331)

Event Type  No Answer Provided  

Event Description

The user facility reported two employees experienced a headache and watering eyes while using prolystica 2x enzymatic presoak and cleaner.The employees subject of the reported event did not seek medical treatment.

Manufacturer Narrative

The user facility confirmed the employees were wearing appropriate ppe and air exchanges within the room were adequate.Both employees returned to work and were reassigned to a different area.The instructions for use and label for prolystica 2x enzymatic presoak and cleaner state, "warning: irritating to eyes and skin.Prolonged or frequently repeated contact to subtilisins [found within this product] may cause allergic reactions in some individuals." no additional issues have been reported.

• 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: 4899440
• MDR Text Key: 6022699
• Report Number: 1937531-2015-00007
• 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: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 06/12/2015
• 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