MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT ICE IT; REUSABLE ICE PACK

Model Number 516

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/18/2014

Event Type  malfunction  

Event Description

Purchased from a pharmacy.The ice pack was frozen solid and she didn't know it wasn't suppose to be used only one in the shoulder system, also bought a knee one 512 and they are frozen solid.Received a server burn.It is getting better but still has blisters.

Manufacturer Narrative

The description of use by the user is in direct conflict with the instructions for use.The ice packs should not be used in direct contact with the user.A holster is provided to create an insulation barrier between the ice pack and tissue.Testing on the returned ice packs show that they remained flexible after 4 days in an 8f freezer.Typically, these ice packs will remain flexible to temperatures near 0f.Based on this information, we concluded that the frostbite was a result of improper application the product by the user that was stored at a temperature near 0f.

• Brand Name: ICE IT
• Type of Device: REUSABLE ICE PACK
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; fremont IN
• Manufacturer Contact: randy newsome ; 702 south reed street; fremont, IN 46737 ; 2699626181
• MDR Report Key: 4206860
• MDR Text Key: 5042676
• Report Number: 1811605-2014-00194
• Device Sequence Number: 1
• Product Code: IME
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1