MAUDE Adverse Event Report: RAPID AID CORP INSULATED HOT PACK, LARGE, 6X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	30104
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported heat pack was placed directly on skin of lower back and caused 2nd degree burn.No medication was given as patient reported the issue to the staff after discharge.
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Additional Manufacturer Narrative
This report was filed in error.Cardinal health is not the legal manufacturer of this device.The legal manufacturer is rapid aid in mississauga, ontario canada.The manufacturer has been notified of the event.

• Brand Name: INSULATED HOT PACK, LARGE, 6X9IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): RAPID AID CORP; cau ha a hamlet; quang trung commune; an lao district, haiphong city ; VM
• Manufacturer (Section G): RAPID AID CORP; cau ha a hamlet; quang trung commune; an lao district, haiphong city ; VM
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874152
• MDR Report Key: 17716523
• Report Number: 1423537-2023-00987
• Device Sequence Number: 6982384
• Product Code: IMD
• UDI-Device Identifier: 00630140039839
• UDI-Public: 630140039839
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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
• Device Model Number: 30104
• Device Catalogue Number: 30104
• Device Lot Number: VN23045-2021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2023
• 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 Age: 68 YR
• Patient Sex: Male