MAUDE Adverse Event Report: MO016 MO-MOBERLY COLD PACK, XSMALL, 5X5.5IN, BULK; PACK, HOT OR COLD, DISPOSABLE

Model Number	103B
Health Effect - Clinical Codes	Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record review was completed on the reported lot v6b078.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.At the time of this investigation the sample was not returned, therefore the root cause could not be determined.A corrective action will not be initiated at this time, however the manufacturing site will keep monitoring the incoming complaints.
Event or Problem Description
Patient reports that she had surgery at (b)(6) in (b)(6) and that the hospital provided her with four cardinal health ice packs.On or around (b)(6) 2018 patient states she squeezed and shook the 2 she hadn't used, one was catalog number 103b lot v6b078 and reportedly wrapped it in a towel and placed it on her lower back.She reports that she reportedly woke up to 2nd degree thermal burns from the cold pack(s).She reports she has been seen in the emergency room (er) on 2 occasions and was provided pain medication through an iv (dilaudid and fentanyl).She was provided a medication for nausea.She was given antibiotic ointment to administer 3 times a day and was told to wash and wrap the wound.There was redness and blisters on her lower back.She reports they have now scabbed and are peeling.
Additional Manufacturer Narrative
One sample was received by the manufacturing site on 7/12/2018 for investigation from the customer.The sample review did not identify any issues with the product therefore a root cause for the issue reported could not be confirmed.A dhr review was completed on the reported lot v6b078.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.A corrective action will not be initiated at this time, but the manufacturing site will continue monitoring incoming complaints.

• Brand Name: COLD PACK, XSMALL, 5X5.5IN, BULK
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 7671407
• Report Number: 1423537-2018-00222
• Device Sequence Number: 16355810
• Product Code: IMD
• UDI-Device Identifier: 00888499007409
• UDI-Public: 00888499007409
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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: 103B
• Device Catalogue Number: 103B
• Device Lot Number: V6B078
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/07/2018
• 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: 47 YR
• Patient Weight: 70