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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 STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. V-PRO STERILIZER Back to Search Results
Event Date 12/12/2012
Event Type  No Answer Provided  
Event Description

The user facility reported that after a completed cycle an employee removed a pack from the sterilizer and "burned" her hand. No blister was present. Another employee went to remove the instrument from the pack and obtained a "burn". No blister was present. Both employees went to the emergency room and washed their hands and applied otc ointment. The employee who removed the pack was sent home for the remainder of the day and the other employee returned to her normal work duties. The employee's are fine with no sustaining injuries.

 
Manufacturer Narrative

A steris service technician inspected the unit and found it to be operating properly; no issues were noted. The technician ran two cycles which both completed successfully. The operator manual states (2-2), "failure to thoroughly clean and dry articles to be sterilized could result in an ineffective sterilize cycle". The employees were 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". The technician stated that all employees are now wearing gloves when operating the sterilizer; specifically unloading packs.

 
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Brand NameV-PRO 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 Key2908004
Report Number3005899764-2013-00001
Device Sequence Number1
Product CodeMLR
Report Source Manufacturer
Source Type User facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/10/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2013
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 Received12/12/2012
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: 01/10/2013 Patient Sequence Number: 1
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