MAUDE Adverse Event Report: CARDINAL HEALTH HOT PAK MED 6 X 6.5; HEEL WARMER

Model Number 11450-040

Device Problem Leak/Splash (1354)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

A review was completed on the dhr for catalog number 11450-040, lot v5a010.The lot was found to have been manufactured and released per predetermined specifications.No anomalies were found in the review of the records.Since no sample was provided, we cannot confirm if there was a failure of the thermal packs seal.Without a sample being provided, a more detailed investigation cannot be completed.The plant¿s quality system mandates suitable in-process controls to measure seal integrity of representative samples.Samples are pulled from production and tested at predetermined locations to best gauge the seal integrity.All lots released by the quality unit meet the predetermined criteria.It should be noted that there are not chemicals present that would produce gases or other ¿explosive¿ elements when the pack is activated.Unique device identifier = (b)(4).

Event Description

Based on the report received by the customer, the contents of the hot pak landed on the patient face.Artificial tear ointment was applied to the patents eyes after they were flushed with water for 30 minutes.Per the nurse manager the patient is doing well.

• Brand Name: HOT PAK MED 6 X 6.5
• Type of Device: HEEL WARMER
• Manufacturer (Section D): CARDINAL HEALTH; 808 highway 24 w; moberly MO 65270
• Manufacturer (Section G): CARDINAL HEALTH 200, LLC; 808 w highway 24; moberly MO
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 5462118
• MDR Text Key: 39089849
• Report Number: 1423537-2016-00007
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 11450-040
• Device Catalogue Number: 11450-040
• Device Lot Number: V5S082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/25/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR