STERRAD SEALSURE CHEMICAL INDICATOR TAPE 14202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-07-18 for STERRAD SEALSURE CHEMICAL INDICATOR TAPE 14202 manufactured by Advanced Sterilization Products.

Event Text Entries

[80408783] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[80408784] A customer reported the sterrad? Sealsure chemical indicator tape did not change color correctly after a completed sterad? Nx cycle. The affected load was released and used on a patient. There is no report of infection, injury or harm to patient(s) associated with this issue. Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined in this situation sterility cannot be assured. Therefore, as a matter of policy asp had decided to report all incidents of sterrad? Sealsure chemical indicator tape not changing color correctly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2084725-2017-00515
MDR Report Key6723466
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-07-18
Date of Report2017-06-23
Date of Event2017-06-23
Date Mfgr Received2018-08-16
Device Manufacturer Date2015-10-05
Date Added to Maude2017-07-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMR. JOAQUIN KURZ
Manufacturer Street33 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone949789-383
Manufacturer G1ADVANCED STERILIZATION PRODUCTS
Manufacturer Street33 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTERRAD SEALSURE CHEMICAL INDICATOR TAPE
Generic NameINDICATOR, CHEMICAL
Product CodeJOJ
Date Received2017-07-18
Catalog Number14202
Lot Number27815
Device Expiration Date2017-08-31
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerADVANCED STERILIZATION PRODUCTS
Manufacturer Address33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.