MAUDE Adverse Event Report: DENOVO PRODUCTS, LLC; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Catalog Number 355

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

Event Type  malfunction  

Event Description

One of the newborn heel warmers spontaneously exploded in the supply room.Upon discovering the issue, remaining heel warmers were removed, supply tray was washed with soap and water.Nurse manager was notified.A patient was not involved.

• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): DENOVO PRODUCTS, LLC; 15880 chief court; fort myers FL 33912
• MDR Report Key: 17824366
• MDR Text Key: 324347472
• Report Number: 17824366
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2023

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 Catalogue Number: 355
• Device Lot Number: 012023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1