MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. INSTANT COLD PACK

Catalog Number MDS137020

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 10/03/2014

Event Type  Injury  

Event Description

The end user was diagnosed with a second degree burn in the area where the cold pack was placed following a spinal injection.

Manufacturer Narrative

The end user had a spinal injection and the cold pack was applied to the right lower back directly on her skin prior to discharge.No obvious leaking was observed at that time.The next day she presented with a second degree burn to her right lower back and upper buttock.Her primary care physician was notified and she was prescribed a topical cream.The end user did not return the sample to the facility for evaluation.The warning on the packaging clearly states that the cold pack should be wrapped in a cloth and not be placed directly on the skin.This is a single use device.The end user told the contact at the facility that she had not frozen and reused the pack.We have not identified a root cause and have not confirmed that the device actually caused the reported burn but due to the injury and need for medical intervention, this medwatch is being filed.

• Brand Name: INSTANT COLD PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4278964
• MDR Text Key: 5033389
• Report Number: 1417592-2014-00106
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/14/2014

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS137020
• Device Lot Number: 136783168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR