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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEEL SNUGGLER

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PHILIPS HEEL SNUGGLER Back to Search Results
Device Problem Burst Container or Vessel (1074)
Patient Problem No Information (3190)
Event Date 04/04/2016
Event Type  malfunction  
Event Description
Hand activated heel warmer pack exploded when being massaged for activation.The actual heel warmer was discarded.Reference number (b)(4) and printed number on same product bag is (b)(4).
 
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Brand Name
HEEL SNUGGLER
Type of Device
HEEL SNUGGLER
Manufacturer (Section D)
PHILIPS
MDR Report Key5573280
MDR Text Key42629986
Report NumberMW5061640
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 04/08/2016
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 No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/08/2016
Type of Device Usage N
Patient Sequence Number1
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