MAUDE Adverse Event Report: MO016 MO-MOBERLY HOT PACK, LARGE, 6X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	11443-012B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported, one hot pack exploded when an employee was using.Operator of the device is unknown.No further information was provided upon request.
Additional Manufacturer Narrative
Samples were received for evaluation, and the investigation determined that the samples were pre-activated; they had not been activated by a user nor had the samples burst.The reported defect of burst was unconfirmed and the root cause remains unknown.Device history record review was completed on the reported lot v2k116, and the lot was manufactured and released in compliance with all requirements.Cardinal health will continue to monitor complaint trends for this reported issue of burst and work to identify improvement activities to minimize reoccurrence.

• Brand Name: HOT PACK, LARGE, 6X9IN
• 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: 16773298
• Report Number: 1423537-2023-00911
• Device Sequence Number: 19617878
• Product Code: IMD
• UDI-Device Identifier: 10885380169267
• UDI-Public: 10885380169267
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2023

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
• Device Model Number: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: V2K116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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 Sex: Unknown