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

Model Number 355NW

Device Problem Premature Activation (1484)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2018

Event Type  malfunction  

Event Description

Eight devices from two different lot numbers came already activated and were unable to be utilized by this facility.(six devices from lot# 060418a and two devices from lot# 051818a).

• Brand Name: DENOVO GEL INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): DENOVO PRODUCTS LLC; 17051 alico commerce court; unit 3; fort myers FL 33967
• MDR Report Key: 7850315
• MDR Text Key: 119349841
• Report Number: 7850315
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 355NW
• Device Catalogue Number: 355NW
• Device Lot Number: 060418A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1