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

Model Number V11460-010

Device Problem Burst Container or Vessel (1074)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

Device history review was completed on the reported lot v2s056.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Samples were not returned for evaluation due to which a root cause could not be determined.Cardinal health will continue to monitor trends for this product.

Event Description

Customer reported the infant heel warmer rupture/exploded while activating and the contents went everywhere.One nurse got it in her eyes causing burning and had to use the eye wash station to rinse out her eyes.No injury or medication provided, and the nurse is doing well.No demographics 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: 16845834
• MDR Text Key: 314329811
• Report Number: 1423537-2023-00921
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 10192253061468
• UDI-Public: 10192253061468
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2023

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 Operator: Health Professional
• Device Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: V2S056
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female