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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® STERILIZER 100NX 1-DR STERRAD® EQUIPMENT

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ADVANCED STERILIZATION PRODUCTS STERRAD® STERILIZER 100NX 1-DR STERRAD® EQUIPMENT Back to Search Results
Catalog Number 10104
Device Problem Environmental Particulates
Event Date 07/23/2019
Event Type  Malfunction  
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Brand NameSTERRAD® STERILIZER 100NX 1-DR
Type of DeviceSTERRAD® EQUIPMENT
Manufacturer (Section D)
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine CA 92618
Manufacturer (Section G)
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine CA 92618
Manufacturer Contact
gabriela mclellan
33 technology drive
irvine , CA 92618
949453-639
MDR Report Key8849210
Report Number2084725-2019-00918
Device Sequence Number1
Product CodeMLR
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/23/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number10104
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/20/2012
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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