MAUDE Adverse Event Report: COVIDIEN; HEEL WARMER FOR INFANT

Catalog Number MHOOOO2N

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

Upon activating a heel warmer, it "exploded" in the patient room with the contents going in the patient room.

• Type of Device: HEEL WARMER FOR INFANT
• Manufacturer (Section D): COVIDIEN; minneapolis MN 55432
• MDR Report Key: 4608793
• MDR Text Key: 21933721
• Report Number: MW5041454
• 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: 03/11/2015

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 Catalogue Number: MHOOOO2N
• Device Lot Number: 431672X
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 DA