MAUDE Adverse Event Report: PHILIPS PHILIPS; PAD

Lot Number 081-CB-00036

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Date 02/22/2014

Event Type  malfunction  

Event Description

Blisters to back and posterior right thigh in honeycomb pattern noted immediately after removal of innercool pads used for hypothermia protocol.Dates of use: (b)(6) 2014.

• Brand Name: PHILIPS
• Type of Device: PAD
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 3731814
• MDR Text Key: 4326717
• Report Number: MW5035473
• Device Sequence Number: 1
• Product Code: FOH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2014

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: Other
• Device Lot Number: 081-CB-00036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2014
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 105