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	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples were returned by the customer for evaluation; therefore, the root cause for the issue reported cannot be determined.A review of the device history record for the reported lot v2l190 was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Cardinal health will continue to monitor and trend all similar reported product related issues.
Event or Problem Description
Customer reported that the hot pack exploded on a nurse.No further information was provided.

• 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
• 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: 17578396
• Report Number: 1423537-2023-00981
• Device Sequence Number: 12854011
• Product Code: IMD
• UDI-Device Identifier: 10885380167218
• UDI-Public: 10885380167218
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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: V11443-012B
• Device Catalogue Number: V11443-012B
• Device Lot Number: V2L190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/18/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown