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

Model Number	11450-040B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while squeezing to activate a cardinal health hot pack, fluid from the pack spurted out across the patient¿s right arm and also into the patient¿s eye.Customer has indicated that they cannot provide any additional information on the reported injury, additional treatment or how the pack material was removed from the patient after several requests for this information.
Additional Manufacturer Narrative
Device history review was completed on the reported lot number v1k164.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.70 samples were received and reviewed.The samples were not activated.The samples were visually inspected, activated, and then inspected again for reported failure mode.The failure mode was unable to be confirmed via evaluation of the returned samples.A warning is being added to the label which instructs customer to activate away from all people.The manufacturing site will continue to monitor complaint trends.

• Brand Name: HOT PACK, MEDIUM, 6X6.5IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 12713194
• Report Number: 1423537-2021-00685
• Device Sequence Number: 11899860
• Product Code: IMD
• UDI-Device Identifier: 10885380167188
• UDI-Public: 10885380167188
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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: 11450-040B
• Device Catalogue Number: 11450-040B
• Device Lot Number: V1K164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/28/2021
• Patient Sequence Number: 1