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U.S. Department of Health and Human Services

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

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STERIS MEXICO, S. DE R.L. DE C.V. V-PRO MAX STERILIZER Back to Search Results
Event Date 01/08/2013
Event Type  No Answer Provided  
Event Description

The user facility reported that an employee retrieved a pack from the spd and proceeded to bring the pack into an operating room. The pack was opened and the employee placed the chemguard from the pack in between her legs and obtained "burns" to her inner thighs. She also obtained "burns" to her hands. The employee washed her hands with soap and water immediately. No blistering was present. The employee stated that she made an appointment to see her dermatologist. Steris was informed that the employee returned to normal work duties. No procedural delays or cancellations reported.

 
Manufacturer Narrative

A steris service technician inspected the unit and found it to be operating properly; no issues were noted. The user facility stated that a wet spot was noted on the inside of the pack. The employee was not wearing proper ppe (gloves) at the time of the reported event. The operator manual states (2-1), "ppe - personal protective equipment including goggles or face shield and chemical-resistant gloves. Ppe required per task will vary depending upon hazards of the task". Steris conducted in-service training on (b)(4) 2013 on the proper use and operation of the v-pro sterilizer, specifically the importance of wearing proper ppe.

 
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Brand NameV-PRO MAX STERILIZER
Type of DeviceSTERILIZER
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
lindsey mcgowan
5960 heisley road
mentor , OH 44060
4403927519
MDR Report Key2929919
Report Number3005899764-2013-00003
Device Sequence Number1
Product CodeMLR
Report Source Manufacturer
Source Type User facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/25/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/25/2013
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 Received01/08/2013
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 TREATMENT DATA
Date Received: 01/25/2013 Patient Sequence Number: 1
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