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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. 16" CENTURY STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 16" CENTURY STERILIZER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 12/14/2017
Event Type  malfunction  
Manufacturer Narrative
During the time of the reported event, the employee opened the door of the unit to warm up her body and hot water came in contact with her hand, resulting in a burn. The employee sought medical treatment and returned to work. A steris service technician arrived onsite following the reported event. While onsite, the technician confirmed the employee used the sterilizer as a heat source to warm up and was not wearing any ppe during the time of the reported event. The technician confirmed that a cycle was not in process during the time of the reported event. It could not be confirmed when the unit was used prior to the reported event. The century vac. Steam sterilizer's operator manual states (p. 1-1), "sterilizer, rack/shelves, and loading car will be hot after cycle is run. " the technician ran a cycle and found the unit to be working according to specifications. The technician counseled the user facility on proper use and operation of the century vac. Steam sterilizer. No additional issues reported.
 
Event Description
The user facility reported that an employee obtained a burn from their 16" century steam sterilizer.
 
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Brand Name16" CENTURY 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 67190
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key7179245
MDR Text Key96970182
Report Number3005899764-2018-00003
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2017
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

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