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	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not returned for investigation; therefore, an evaluation of the complaint device for deficiency of construction could not be performed and the root cause remains unknown.Device history record review was completed on the reported lot number v2j079.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.No further action will be taken at this time.Cardinal health will continue to monitor complaint trends for this reported issue.
Event or Problem Description
Customer reported male patient popped the hot pack himself, and the chemicals leaked on his shirt and hands.Patient encouraged to wash his hands, and he was provided a new shirt.No harm was noted.

• 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 drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 16474545
• Report Number: 1423537-2023-00882
• Device Sequence Number: 7579362
• Product Code: IMD
• UDI-Device Identifier: 10885380167195
• UDI-Public: 10885380167195
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

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: Lay User/Patient
• Device Model Number: V11450-040B
• Device Catalogue Number: V11450-040B
• Device Lot Number: V2J079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2022
• 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 Age: 19 YR
• Patient Sex: Male
• Patient Weight: 66 KG