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

Model Number	V11460-010
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1423537-2023-00921
• Device Sequence Number: 15340327
• Product Code: MPO
• UDI-Device Identifier: 10192253061468
• UDI-Public: 10192253061468
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: V2S056
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female