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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 1 STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. V-PRO 1 STERILIZER Back to Search Results
Event Date 07/10/2013
Event Type  No Answer Provided  
Event Description

The user facility reported an employee experienced a chemical burn on their hand when operating the v-pro sterilizer. The employee sought treatment. No procedural delays or cancellations were reported.

 
Manufacturer Narrative

During a service visit, the user facility reported to a steris technician that an employee experienced a chemical burn that turned white, on his/her hand while operating the v-pro 1 sterilizer. The employee sought treatment and did not miss any time from work; the user facility declined to release any additional treatment information. Steris has been unable to confirm if the employee was wearing ppe at the time of the event. Reference 2-2, of the v-pro 1 operator manual states: "danger -chemical injury hazard: when handling hydrogen peroxide, wear appropriate personal protective equipment and observe all safety precautions. " the steris service technician counseled the user facility on the importance of wearing ppe when operating the v-pro 1 sterilizer.

 
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Brand NameV-PRO 1 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
kathryn cadorette
5960 heisley road
mentor , OH 44060
4403927231
MDR Report Key3273562
Report Number3005899764-2013-00080
Device Sequence Number1
Product CodeFLE
Report Source Manufacturer
Source Type User facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/09/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2013
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 Received07/10/2013
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: 08/09/2013 Patient Sequence Number: 1
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