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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MCKESSON MCKESSON; INFANT HEEL WARMER
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MCKESSON MCKESSON; INFANT HEEL WARMER Back to Search Results
Model Number 59-45HW
Device Problem Overheating of Device (1437)
Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Event Date 06/05/2017
Event Type  Injury  
Event Description
One (b)(6), child was brought to clinic for metabolic screening.A heel warmer was applied to the left foot for heel stick.The screening was incomplete so another heel warmer was placed on the right foot.The screening was completed with no notable blisters.On (b)(6), two other nurses noted that the heel warmers were too warm.Supervisor was notified and product was withdrawn from use.On june 13th, the parent emailed a complaint and pictures of the child with blisters on feet bilaterally.A telephone call was attempted and message left to call clinic.On june 15th, an email was sent to the parent to contact the clinic.On june 19th, the parent responded stating that the child was seen in er and referred to a hospital burn center.The child is recovering.
 
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Brand Name
MCKESSON
Type of Device
INFANT HEEL WARMER
Manufacturer (Section D)
MCKESSON
MDR Report Key6666594
MDR Text Key78464439
Report NumberMW5070601
Device Sequence Number1
Product Code MPO
UDI-Device Identifier10612479153421
UDI-Public10612479153421
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number59-45HW
Device Lot NumberLP-49801104
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/22/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age12 DA
Patient Weight3
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