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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOTECH NEOTECH; NEOLEAD ECG ELECTRODS
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NEOTECH NEOTECH; NEOLEAD ECG ELECTRODS Back to Search Results
Model Number N301
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Actual device was returned and issue was confirmed.(b)(4) was opened and a supplier corrective action report (b)(4) for our contract manufacturer, r&d medical products, inc.Was issued on (b)(4) 2016.
 
Event Description
Customer opened a neolead n301 pouch and found a razor blade inside.Packaging or contents did not come in contact with patients or any other personnel.
 
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Brand Name
NEOTECH
Type of Device
NEOLEAD ECG ELECTRODS
Manufacturer (Section D)
NEOTECH
28430 witherspoon parkway
valencia 91355
Manufacturer (Section G)
NEOTECH PRODUCTS, INC.
28430 witherspoon pkw
valencia CA 91355
Manufacturer Contact
leo arya
28430 witherspoon parkway
valencia, CA 91355
6617757466
MDR Report Key6147754
MDR Text Key61543796
Report Number2025917-2016-00113
Device Sequence Number1
Product Code DRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011564
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Remedial Action Inspection
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2017
Device Model NumberN301
Device Catalogue NumberN301
Device Lot Number2015-9041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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