MAUDE Adverse Event Report: MO016 MO-MOBERLY HOT PACK, LARGE, 6X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	11443-012B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported one hot pack from lot v2s197 caused an employee injury when it leaked contents onto nurse hand.She received a second degree burn and it was treated with over-the-counter bacitracin.The leaking hot pack was saved.
Additional Manufacturer Narrative
This complaint was forwarded to the manufacturing facility where it is currently under investigation.A follow up report will be filed once the results have been completed.
Additional Manufacturer Narrative
Supplemental report is being filed following the submission of the initial mdr report submitted on 04/18/2023 since a sample was returned for investigation.Device history record was reviewed for the reported lot number, v2s197.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.One activated sample was returned for investigation, but we were unable to confirm the reported failure.The manufacturing site will continue to monitor complaint trends.

• Brand Name: HOT PACK, LARGE, 6X9IN
• 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 drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 16766153
• Report Number: 1423537-2023-00910
• Device Sequence Number: 3063773
• Product Code: IMD
• UDI-Device Identifier: 10885380169267
• UDI-Public: 10885380169267
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: V2S197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female