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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. EVOLUTION LOADING CART EVOLUTION LOADING CART TO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. EVOLUTION LOADING CART EVOLUTION LOADING CART TO STERILIZER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 04/12/2017
Event Type  Malfunction  
Manufacturer Narrative

The employee sought and received medical treatment. A steris service technician inspected the loading cart and found it to be operating properly. The technician did not identify any sharp areas on the loading cart that could have caused the reported event. The technician interviewed user facility personnel to determine the root cause of the reported injury. The user facility could not demonstrate or identify where on the loading cart the employee obtained the reported injury. As the loading cart was found to be operating properly without any sharp edges or burrs, it was returned to service. No additional issues have been reported.

 
Event Description

The user facility reported that an employee obtained a cut on their hand while operating the evolution loading cart.

 
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Brand NameEVOLUTION LOADING CART
Type of DeviceEVOLUTION LOADING CART TO STERILIZER
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
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key6560179
MDR Text Key75104721
Report Number3005899764-2017-00019
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 05/11/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/11/2017
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2017
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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