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MAUDE Adverse Event Report: PHILIPS HEEL SNUGGLER
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PHILIPS HEEL SNUGGLER
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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 Key
5573280
MDR Text Key
42629986
Report Number
MW5061640
Device Sequence Number
1
Product Code
MPO
Reporter Country Code
US
Number of Events Reported
1
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 Received
04/08/2016
Type of Device Usage
N
Patient Sequence Number
1
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