MAUDE Adverse Event Report: CARDINAL HEALTH MOBERLY INSULATED HOT PACK, LARGE, 6X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	30104
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history review (dhr) review was completed on the reported lot v7s194.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.According to american society for testing and materials (astm) standard 1055-99e on burns, the lowest temperature where epidermis injury occurs is at a constant 111.2 degrees fahrenheit for a minimum exposure of 16 continual minutes.The maximum temperature the cardinal health product (30104) can reach is 111.8 degrees fahrenheit (110 ± 1.8 °f).Once activated, the product reaches max temperature immediately after activation, after which the temperature drops below 110.0 ± 1.8 degrees fahrenheit within minutes of being activated.At the time of this investigation no samples were provided.Since no samples were available the root cause could not be determined.At this time, no corrective action will be taken.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature.
Event or Problem Description
Based on a medwatch filed by the customer and interaction with the customer, it was reported two hot packs were applied for patient comfort.The two hot packs were handed to the patient.Reportedly, the patient fell asleep with them under her, causing partial thickness burns l 17cm x w 15cm.The patient required minor treatment from wound care and burn team.It was recommended daily wound care by rn team, pre-medication as needed (prn) before wound care, clean with 4% chlorhexidine wipes or johnson and johnson baby soap with water, pad dry, apply thin layer of santyl/ collagenase over wound, cover with mepilex lite dressing and support with tape.

• Brand Name: INSULATED HOT PACK, LARGE, 6X9IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 7464968
• Report Number: 1423537-2018-00193
• Device Sequence Number: 16551709
• Product Code: IMD
• UDI-Device Identifier: 50630140039834
• UDI-Public: 50630140039834
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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: 30104
• Device Catalogue Number: 30104
• Device Lot Number: V7S194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR