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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. CENTURY STERILIZER
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STERIS MEXICO, S. DE R.L. DE C.V. CENTURY STERILIZER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 12/26/2018
Event Type  malfunction  
Manufacturer Narrative
Review of service records indicates that the user facility has not contacted steris regarding an injury associated with a century sterilizer prior to contacting the steris legal department.A steris service technician is contacting the user facility to schedule an inspection of the century sterilizer.A follow-up mdr will be submitted when additional information becomes available.
 
Event Description
The steris legal department was contacted on 8/26/2019 regarding an alleged injury involving a century sterilizer occurring on (b)(6) 2018.The exact nature of the alleged injury is unknown.
 
Manufacturer Narrative
A steris service technician arrived onsite to inspect the century sterilizer; however, the user facility did not allow the technician to inspect the sterilizer.A follow-up mdr will be submitted should additional information become available.
 
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Brand Name
CENTURY STERILIZER
Type of Device
STERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX  67190
MDR Report Key9120638
MDR Text Key199550380
Report Number3005899764-2019-00081
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/26/2019
Initial Date FDA Received09/25/2019
Supplement Dates Manufacturer Received08/26/2019
Supplement Dates FDA Received10/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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