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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples were returned for evaluation, therefore a root cause could not be determined at this time.A review of the device history record could not be performed as a lot number was not provided.Cardinal health will continue to monitor and trend all reported product related issues.
Event or Problem Description
Customer reported that the clinician popped the heel warmer like normal, no extra force, near the bedside in triage.It exploded towards the foot of the bed at patient's shoulder with gel getting on his jacket.It also got on clinician's scrubs, on patient bed, and on the floor.There was no adverse effect.Event date is unknown.

• 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: 17140014
• Report Number: 1423537-2023-00951
• Device Sequence Number: 17125882
• Product Code: MPO
• UDI-Device Identifier: 10192253061468
• UDI-Public: 10192253061468
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male