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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN; HEEL WARMER FOR INFANT

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COVIDIEN; HEEL WARMER FOR INFANT Back to Search Results
Catalog Number MHOOOO2N
Device Problem Burst Container or Vessel (1074)
Patient Problem No Information (3190)
Event Date 02/18/2015
Event Type  malfunction  
Event Description
Upon activating a heel warmer, it "exploded" in the patient room with the contents going in the patient room.
 
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Type of Device
HEEL WARMER FOR INFANT
Manufacturer (Section D)
COVIDIEN
minneapolis MN 55432
MDR Report Key4608793
MDR Text Key21933721
Report NumberMW5041454
Device Sequence Number1
Product Code MPO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/11/2015
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 NumberMHOOOO2N
Device Lot Number431672X
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/11/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age2 DA
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