MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INFANT HEEL WARMER

Lot Number 100294

Device Problem Burst Container or Vessel (1074)

Patient Problems Burning Sensation (2146); Burn, Thermal (2530)

Event Date 10/26/2018

Event Type  malfunction  

Event Description

Rn and staff at bedside were opening up philips infant heel warmers to place on pt.Staff member across from rn opened up heel warmer and contents were expelled on rn's arm and face.Rn immediately washed off contents and later noticed burning sensation on arm.Superficial burn had developed on rn's arm from heel warmer contents.Rn evaluated in emergency room (er.).

• Brand Name: INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS
• MDR Report Key: 8069507
• MDR Text Key: 127228797
• Report Number: MW5081209
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• 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: 11/07/2018

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 Lot Number: 100294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1