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	Skin Inflammation/ Irritation (4545)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was received and forwarded to the manufacturing facility for investigation.The actual complaint product was discarded by the customer and the lot number was not provided.Without the lot number, the device history record could not be reviewed.Since the actual complaint product was not returned for investigation, the root cause could not be determined.We will continue to monitor complaint trends and utilize the information as part of continuous improvement.
Event or Problem Description
Customer reported hot pack exploded during activation.The issue reportedly caused skin irritation to nurse, but no medication needed.

• 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: 13142574
• Report Number: 1423537-2022-00706
• Device Sequence Number: 11184247
• Product Code: IMD
• UDI-Device Identifier: 30888499004898
• UDI-Public: 30888499004898
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/03/2022

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: 41-1791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female