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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOTECH PRODUCTS LLC NEOLEAD RADIOLUCENT; ELECTRODE, ELECTROCARDIOGRAPH
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NEOTECH PRODUCTS LLC NEOLEAD RADIOLUCENT; ELECTRODE, ELECTROCARDIOGRAPH Back to Search Results
Catalog Number N305
Device Problem Physical Resistance/Sticking (4012)
Patient Problems Skin Tears (2516); Blister (4537)
Event Date 01/23/2023
Event Type  malfunction  
Event Description
Cardiac leads removed following soaking leads in water.Leads still difficult to remove.All sites reddened.Small skin tear present at former right chest lead site.Very small fluid filled blister present at former chest lead site.All sites cleansed with water.All affected lots 2022-9033, -9034, -9035 were pulled from stock and returned to manufacturer.Manufacturer response for radiolucent neolead ecg electrodes, radiolucent neolead ecg electrodes (per site reporter).All affected lots 2022-9033, -9034, -9035 were pulled from stock and returned to manufacturer.
 
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Brand Name
NEOLEAD RADIOLUCENT
Type of Device
ELECTRODE, ELECTROCARDIOGRAPH
Manufacturer (Section D)
NEOTECH PRODUCTS LLC
28430 witherspoon pkwy
valencia CA 91355
MDR Report Key16564176
MDR Text Key311522571
Report Number16564176
Device Sequence Number1
Product Code DRX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberN305
Device Lot Number2022-9033
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/08/2023
Event Location Hospital
Date Report to Manufacturer03/17/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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