MAUDE Adverse Event Report: STERIS CORPORATION - DISTRIBUTION CENTER VAPROX HC STERILANT

Model Number PB011

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that an employee received a burn from vaprox sterilant.

• Brand Name: VAPROX HC STERILANT
• Type of Device: STERILANT
• Manufacturer (Section D): STERIS CORPORATION - DISTRIBUTION CENTER; 6100 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION - DISTRIBUTION CENTER; 6100 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 18453784
• MDR Text Key: 332730696
• Report Number: 3003950207-2024-00001
• Device Sequence Number: 1
• Product Code: MLR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PB011
• Device Catalogue Number: PB011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1