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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NOVAPLUS INFANT HEEL WARMER 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

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CARDINAL HEALTH 200, LLC NOVAPLUS INFANT HEEL WARMER 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK) Back to Search Results
Model Number V11460-010
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/1980
Event Type  malfunction  
Manufacturer Narrative
Device history review (dhr) was completed on the reported lot v2a051.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.A sample was not returned for investigation, therefore a root cause could not be determined.We will continue to monitor trends for this product.
 
Event Description
Customer reported that when activating the infant heel warmer as instructed, it burst and contents went across the room hitting staff member¿s jacket.There was no skin exposure or adverse event.Event date is unknown.
 
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Brand Name
NOVAPLUS INFANT HEEL WARMER 4X4IN
Type of Device
INFANT HEEL WARMER (CHEMICAL HEAT PACK)
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
3651 birchwood drive
waukegan IL 65270
Manufacturer (Section G)
MO016 MO-MOBERLY
808 w highway 24
moberly MO 65270
Manufacturer Contact
patricia tucker
3651 birchwood dr
waukegan, IL 60085
8878474151
MDR Report Key14598381
MDR Text Key301092199
Report Number1423537-2022-00776
Device Sequence Number1
Product Code MPO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/03/2022
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 Model NumberV11460-010
Device Catalogue NumberV11460-010
Device Lot NumberV2A051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/09/2022
Initial Date FDA Received06/03/2022
Date Device Manufactured01/10/2022
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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