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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record review was completed on the reported lot #v1l141.The lot was found to have been manufactured and released to predetermined specifications and no anomalies were found during review of the records.We received 1 sample on 12/20/2021.The sample was received activated.The root cause was determined to be an incomplete top seal resulting from production personnel not following internal procedure.Issue will be monitored through routine complaint trend analysis and personnel will be retrained on internal standard production methods.Additionally, a warning label is being added to the label of the device that specifies that ¿when activating, hold away from patient.¿ we will continue to monitor complaint trends and utilize the information as part of continuous improvement.
Event or Problem Description
It has been reported that a cardinal health hot pack burst onto a nurse¿s shirt, down the lower half of her trunk and down both legs of her pants (upper thighs and shins).There was mild skin irritation where the contents of the package came into contact with the skin.The nurse reported that she brushed off as much of the material as possible with a washcloth at the time of the pack bursting.Once home, she removed clothing and washed her skin with soap and water.The irritation subsided with no significant or lasting injury.At present, she is doing fine.
Additional Manufacturer Narrative
Device history record review was completed on the reported lot #v1l141.The lot was found to have been manufactured and released to predetermined specifications and no anomalies were found during review of the records.We received 1 sample on 12/20/2021.The sample was received activated.The root cause was determined to be an incomplete top seal resulting from production personnel not following internal procedure.Issue will be monitored through routine complaint trend analysis and personnel will be retrained on internal standard production methods.Additionally, a warning label is being added to the label of the device that specifies that ¿when activating, hold away from patient.¿ we will continue to monitor complaint trends and utilize the information as part of continuous improvement.
Event or Problem Description
It has been reported that a cardinal health hot pack burst onto a nurse¿s shirt, down the lower half of her trunk and down both legs of her pants (upper thighs and shins).There was mild skin irritation where the contents of the package came into contact with the skin.The nurse reported that she brushed off as much of the material as possible with a washcloth at the time of the pack bursting.Once home, she removed clothing and washed her skin with soap and water.The irritation subsided with no significant or lasting injury.At present, she is doing fine.

• 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
• 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: 13056308
• Report Number: 1423537-2021-00701
• Device Sequence Number: 1608527
• Product Code: IMD
• UDI-Device Identifier: 10885380167188
• UDI-Public: 10885380167188
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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: V1L141
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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: A
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female