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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE INFANT HEEL WARMER; PACK, HOT OR COLD, DISPOSABLE
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COVIDIEN ARGYLE INFANT HEEL WARMER; PACK, HOT OR COLD, DISPOSABLE Back to Search Results
Model Number MH00002T
Device Problem Burst Container or Vessel (1074)
Patient Problems Eye Injury (1845); Chemical Exposure (2570)
Event Date 06/07/2014
Event Type  malfunction  
Event Description
The nurse picked up an infant heel warmer and proceeded back to the infant to use the device.While walking back to the basinette, the nurse begain applying light pressure to the pack to begin the mixing of the warming chemicals.The nurse states she used very little pressure and the pack exploded and sprayed her in the eyes with the chemical.The force was great enough to produce splatter on the ceiling in about a 3' radius.The nurse received medical treatment because of eye burning.She was given erythromycin for her eyes and was sent home.The packaging wasn't saved however the remaing lot was removed from serivce.We pulled two cases out of use and the manufacturer is only requesting a few packs for samples.
 
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Brand Name
ARGYLE INFANT HEEL WARMER
Type of Device
PACK, HOT OR COLD, DISPOSABLE
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield street MA 02048
MDR Report Key3904457
MDR Text Key4515769
Report Number3904457
Device Sequence Number3
Product Code MPO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 06/09/2014
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Model NumberMH00002T
Device Catalogue NumberMH00002T
Device Lot Number321826X
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2014
Event Location Hospital
Date Report to Manufacturer07/01/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/09/2014
Patient Sequence Number1
Treatment
EVENT DIDN'T INVOLVE A PATIENT
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