STERILIZATION INDICATOR STRIP * 008060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-16 for STERILIZATION INDICATOR STRIP * 008060 manufactured by Surgicot, Inc..

Event Text Entries

[24024] The sterilization indicator strips (eto) have been unpredictable in changing color when exposed to ethylene oxide. This has occurred repeatedly and in multiple lots. When four strips were sterilized in a single sterilization container, all four showed different color changes. All eto sterilization criteria was met and all other chemical and bacteriological indicators accurately showed this.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4001495
MDR Report Key38043
Date Received1996-09-16
Date of Report1994-11-17
Date Added to Maude1996-09-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSTERILIZATION INDICATOR STRIP
Generic NameSTERILIZATION INDICATOR STRIP
Product CodeLRT
Date Received1996-09-16
Model Number*
Catalog Number008060
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key39315
ManufacturerSURGICOT, INC.
Manufacturer Address4018 PATRIOT DR RESEARCH TRIANGLE PARK NC 27709 US


Patients

Patient NumberTreatmentOutcomeDate
10 1996-09-16

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