260010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for 260010 manufactured by Steris Corporation.

Event Text Entries

[93050804]
Patient Sequence No: 1, Text Type: N, H10


[93050805] Steam sterilization in central sterile/sterile processing was completed using required indicator tape for blue wrapped instruments. This tape did not change as required for validation of sterilization.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7062842
MDR Report Key7062842
Date Received2017-11-28
Date of Report2017-11-15
Date of Event2017-11-10
Report Date2017-11-13
Date Reported to FDA2017-11-13
Date Reported to Mfgr2017-11-13
Date Added to Maude2017-11-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNA
Generic NameINDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
Product CodeJOJ
Date Received2017-11-28
Model Number260010
Catalog Number260010
Lot Number709401
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CORPORATION
Manufacturer Address5960 HEISLEY ROAD MENTOR OH 44060 US 44060


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-28

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