MAUDE Adverse Event Report: CARDINAL HEALTH MOBERLY TWIN INSTANT HOT PACKS, 2 CT; PACK, HOT OR COLD, DISPOSABLE

Model Number	11443-012R
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	08/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a sample being provided, any failure mode or definitive root cause could not be determined. the manufacturing facility's quality system mandates suitable in-process controls to measure the seal integrity of representative samples. during production of this lot, fifty-five samples were pulled and tested at predetermined locations to best gauge the seal integrity by pull test and functional leak testing. all samples pulled from this lot met the predetermined criteria before it was released.  it should be noted that the chemicals used in the product are food grade and non-toxic. the ifu does state that if the contents contact the skin, you should wash the area with mild soap and water. it also states that it should not be applied to broken skin.  during production, the formulation of the product is tested every 2 hours to measure the maximum temperature that it can generate. the tolerance for this process is 110.5 - 114.1 degrees f. again, all samples must meet this tolerance before it is released. based on peak temperature upon activation, a 2nd degree burn is not likely with this product.
Event or Problem Description
Customer reported that on (b)(6) 2016, while vacationing at (b)(6), she sustained a stingray bite on her foot.Customer states that she felt terrible pain and saw a lot of blood coming from the wound on her foot.She fainted.When she came to, she stated she was being attended to by the local lifeguards.She was given a hot pack and was told to go to the local urgent care.By the time she arrived at the urgent care she had three large blisters on the top of her foot.

• Brand Name: TWIN INSTANT HOT PACKS, 2 CT
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 6042588
• Report Number: 1423537-2016-00053
• Device Sequence Number: 11032706
• Product Code: IMD
• UDI-Device Identifier: 00888499002879
• UDI-Public: 00888499002879
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 11443-012R
• Device Catalogue Number: 11443-012R
• Device Lot Number: V5H023
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2016
• Initial Report FDA Received Date: 10/19/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention