MAUDE Adverse Event Report: STERIS CORPORATION VALSURE ALKALINE DETERGENT

Device Problem Chemical Spillage (2894)

Patient Problem No Code Available (3191)

Event Date 12/12/2014

Event Type  No Answer Provided  

Event Description

The user facility reported an employee slipped on valsure alkaline detergent which had been spilt on the floor.The employee subject of the reported event sought and was administered medical treatment.

Manufacturer Narrative

The customer requested information from steris about proper clean-up methods and material.Steris provided a copy of the safety data sheet for valsure alkaline detergent.The employee subject of the reported event sought medical treatment and was treated for bumps and bruises from the fall, but not for chemical burns.

• Brand Name: VALSURE ALKALINE DETERGENT
• Type of Device: DETERGENT
• 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: 4404308
• MDR Text Key: 5366595
• Report Number: 1937531-2015-00001
• 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: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 12/12/2014
• 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