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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; INFANT HEEL WARMER (CHEMICAL HEAT PACK)
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CARDINAL HEALTH 200, LLC CARDINAL HEALTH; INFANT HEEL WARMER (CHEMICAL HEAT PACK) Back to Search Results
Model Number 11460-010T
Device Problem Burst Container or Vessel (1074)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/31/2021
Event Type  malfunction  
Event Description
Narrative from staff: rn went to squeeze heel warmer pack with normal non-aggressive or excessive force using recommended 1 hand technique and the internal contents shot out of the top of the pack hitting the wall, the floor, this nurse's arm and small amounts in hair narrowly missing eye area.Rn quickly washed hands and areas of exposure and cleaned up mess.Manufacturer response for heel warmer, infant heel warmer (per site reporter): we returned to the manufacturer representative via mail.
 
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Brand Name
CARDINAL HEALTH
Type of Device
INFANT HEEL WARMER (CHEMICAL HEAT PACK)
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
3651 birchwood drive
waukegan, IL 60085
MDR Report Key12127505
MDR Text Key260266591
Report Number12127505
Device Sequence Number1
Product Code MPO
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 07/01/2021
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 Number11460-010T
Device Catalogue Number11460-010T
Device Lot NumberV1A041 B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/01/2021
Event Location Hospital
Date Report to Manufacturer07/07/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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