MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO 1 STERILIZER

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Date 02/21/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that after a completed cycle an employee was removing instrument pouches and noticed liquid droplets on the outside.The employee began to feel a burning sensation on their hand.The employee sought and received medical treatment.The employee is fine and is back to work.No procedural delays/cancellations reported.

Manufacturer Narrative

Steris inspected the v-pro 1 sterilizer and found it to be operating properly; no issues were noted and the sterilizer was operating to specifications.The steris regional consumables manager trained the employees on the proper use and operation of v-pro 1 sterilizer.

• Brand Name: V-PRO 1 STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3690539
• MDR Text Key: 16685846
• Report Number: 3005899764-2014-00020
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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