MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS INFANT HEEL WARMER SQUEEZE; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number V11460-010

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

At the time of this investigation, the device history record could not be verified as a lot number was not provided.A sample was not returned for evaluation; therefore, a root cause could not be determined.We will continue to monitor complaint trends and utilize the information as part of continuous improvement.

Event Description

Medwatch report states the novaplus infant heel warmer packets (teal/white packaging) is "exploding" when activated.When squeezed to activate the contents, the seal on the packaging opens up and the contents spray across the area.One staff has made contact with her skin and caused some irritation.Defective item did not reach the baby.No customer contact information provided.

• Brand Name: NOVAPLUS INFANT HEEL WARMER SQUEEZE
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 16849628
• MDR Text Key: 314383528
• Report Number: 1423537-2023-00915
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 10192253061468
• UDI-Public: 10192253061468
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1