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	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record review was completed on the reported lot number, v1c212.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.One sample was received for investigation.Visual evaluation of the returned sample revealed it was already activated, and it appears to have been cut with a sharp instrument.It is likely the pouch was cut when the product shipper was being opened at the customer¿s location.Employees at the manufacturing site do not use sharp instruments to open shippers.Additionally, the shipper¿s artwork instructs customers to not use a knife to open.Therefore, the root cause is likely due to the customer failing to follow packaging directions.We will continue to monitor complaint trends and utilize the information as part of continuous improvement.
Event or Problem Description
Customer reported, while attempting to activate heat pack, it exploded in my eyes, chest, head, hands, neck.Eye wash was done two times and saline flushes used to flush out eyes.Reportedly, large particles of debris removed from my eyes.Initially i could not see and had severe burning to my eyes.After flushing my eyes no burning noted, just dryness.

• 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: 13847325
• Report Number: 1423537-2022-00740
• Device Sequence Number: 14619841
• Product Code: IMD
• UDI-Device Identifier: 10885380167188
• UDI-Public: 10885380167188
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2022

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: V1C212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown