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

Model Number 11450-040B

Device Problem Burst Container or Vessel (1074)

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

Event Date 11/29/2021

Event Type  malfunction  

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 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.

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 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
• 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: 13056308
• MDR Text Key: 286139183
• Report Number: 1423537-2021-00701
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380167188
• UDI-Public: 10885380167188
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 11450-040B
• Device Catalogue Number: 11450-040B
• Device Lot Number: V1L141
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female