MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS HOT PACK, LARGE, 6X9; PACK, HOT OR COLD, DISPOSABLE

Model Number	V11443-012B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported lot number for the actual complaint sample was not provided.No samples were returned for investigation; therefore, the root cause could not be determined.The customer indicated in the complaint they had lot numbers v1d057 and v1d036 in their warehouse.Device history reviews were completed on these lot numbers, and they were both found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.We will continue to monitor complaint trends for this type of incident.
Event or Problem Description
Customer reported hot pack burst and contents landed on team member's hand and sleeve of lab coat.The team member involved reported that the hot pack was not yet activated, but two team members reportedly heard a popping sound just prior to the pack bursting.The team member experienced a burning sensation.No medications or treatment provided, team member rinsed contents off.

• Brand Name: NOVAPLUS HOT PACK, LARGE, 6X9
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 12380602
• Report Number: 1423537-2021-00667
• Device Sequence Number: 4407313
• Product Code: IMD
• UDI-Device Identifier: 10885380167218
• UDI-Public: 10885380167218
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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: No Information
• Device Model Number: V11443-012B
• Device Catalogue Number: V11443-012B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/27/2021
• Patient Sequence Number: 1