MAUDE Adverse Event Report: MO016 MO-MOBERLY HOT PACK, SMALL, 4.5X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number 11443-512B

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

No samples were returned for investigation; therefore, a root cause could not be determined at this time.A review of the device history record could not be performed as a lot number was not provided.No corrective actions have been taken at this time based on the information provided for this report.Cardinal health will continue to monitor complaint trends for this reported issue.

Event Description

While activating the heat pack to warm a patient¿s hand the heat pack burst, and the contents went into team member¿s right eye.She was taken to the emergency department.There has been no additional information received after making several requests for clinical information.

• Brand Name: HOT PACK, SMALL, 4.5X9IN
• Type of Device: 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: 16284529
• MDR Text Key: 308837392
• Report Number: 1423537-2023-00874
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380168406
• UDI-Public: 10885380168406
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11443-512B
• Device Catalogue Number: 11443-512B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female