MAUDE Adverse Event Report: PHILIPS HEEL SNUGGLER

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).

• 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