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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELLEX ISCIENCE, INC. ITRACK 250A; OPHTHALMIC MICROCATHETER
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ELLEX ISCIENCE, INC. ITRACK 250A; OPHTHALMIC MICROCATHETER Back to Search Results
Model Number ITRACK
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 07/21/2014
Event Type  malfunction  
Event Description
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.
 
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Brand Name
ITRACK 250A
Type of Device
OPHTHALMIC MICROCATHETER
Manufacturer (Section D)
ELLEX ISCIENCE, INC.
4055 campbell avenue
menlo park CA 94025
Manufacturer Contact
lisa sims
4055 campbell avenue
menlo park, CA 94025
6504212757
MDR Report Key4085418
MDR Text Key4741786
Report Number3005641545-2014-00001
Device Sequence Number1
Product Code MPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080067
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 08/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2014
Device Model NumberITRACK
Device Catalogue NumberIT-250A
Device Lot Number1404-03
Other Device ID Number(01)00893872001059
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/01/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3005641545-08/11/14-001R
Patient Sequence Number1
Patient Outcome(s) Other;
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