MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS HOT PACK, MEDIUM, 6X6.5; PACK, HOT OR COLD, DISPOSABLE

Model Number	V11450-040B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was received and forwarded to the manufacturing facility for investigation.Device history record review was not completed because a lot number was not provided by the customer.No sample was returned for investigation; therefore a root cause could not be determined.We will continue to monitor trends and utilize the information as part of continuous improvement.
Event or Problem Description
Hot pack burst during activation and contents splashed on the clinician¿s chest, hands, and face.No injury, just washed with soap and water.No demographics provided for the nurse.

• Brand Name: NOVAPLUS HOT PACK, MEDIUM, 6X6.5
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• 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 dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13779698
• Report Number: 1423537-2022-00736
• Device Sequence Number: 1805356
• Product Code: IMD
• UDI-Device Identifier: 10885380167195
• UDI-Public: 10885380167195
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/15/2022

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: V11450-040B
• Device Catalogue Number: V11450-040B
• Device Lot Number: V11450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown