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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELKA CORPORATION NOVAPLUS DIGITAL THERMOMETER, PEDIATRIC, DUCK CAP; THERMOMETER, ELECTRONIC, CLINICAL
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ELKA CORPORATION NOVAPLUS DIGITAL THERMOMETER, PEDIATRIC, DUCK CAP; THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Catalog Number VDTS-100D
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2022
Event Type  malfunction  
Event Description
When rn removed thermometer from package, duck head came off.This is a safety issue as a child could choke on the head.In addition, there is a button battery right under the duck head.Button batteries can cause serious injury or death if swallowed.Nursing staff suggest manufacturer make the device with a single battery without pop off top.Manufacturer response for pediatric flexible tip digital thermometer, novaplus digital stick thermometer per site reporter.I received an email from manufacturer's official person in addition to a phone call from a elka representative quality team.Device is available for return to the manufacturer for investigation.Awaiting response and mailing labels to process return of product.
 
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Brand Name
NOVAPLUS DIGITAL THERMOMETER, PEDIATRIC, DUCK CAP
Type of Device
THERMOMETER, ELECTRONIC, CLINICAL
Manufacturer (Section D)
ELKA CORPORATION
1707 quincy ave suite 127
naperville IL 60540
MDR Report Key15293465
MDR Text Key298612341
Report Number15293465
Device Sequence Number1
Product Code FLL
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 08/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVDTS-100D
Device Lot Number20210108
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2022
Event Location Hospital
Date Report to Manufacturer08/25/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/25/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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