ITRACK 250A IT-250A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-03 for ITRACK 250A IT-250A manufactured by Ellex Iscience, Inc.

Event Text Entries

[5048948] Two devices from same lot were removed from the packaging and were found to be missing a seal on the sterile barrier pouch and therefore were not sterile. Both devices were detected as not sterile prior to use and were not used for surgery.
Patient Sequence No: 1, Text Type: D, B5


[12515884]
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005641545-2014-00003
MDR Report Key4258667
Report Source05
Date Received2014-09-03
Date of Report2014-08-28
Date of Event2014-08-12
Date Mfgr Received2014-08-12
Device Manufacturer Date2014-04-29
Date Added to Maude2014-11-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLISA SIMS
Manufacturer Street4055 CAMPBELL AVENUE
Manufacturer CityMENLO PARK CA 94025
Manufacturer CountryUS
Manufacturer Postal94025
Manufacturer Phone6504212757
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number3005641545-08/11/14-001R
Event Type3
Type of Report3

Device Details

Brand NameITRACK 250A
Generic NameOPHTHALMIC MICROCATHETER, MPA, MHX
Product CodeMPA
Date Received2014-09-03
Returned To Mfg2014-08-20
Model NumberITRACK
Catalog NumberIT-250A
Lot Number1404-03
ID Number(01)00893872001059
Device Expiration Date2014-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerELLEX ISCIENCE, INC
Manufacturer Address4055 CAMPBELL AVENUE MENLO PARK CA 94025 US 94025


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-09-03

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