MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC. HOT PACK MED 6 X 6.5; HEEL WARMER

Model Number 11450-040

Device Problems Self-Activation or Keying (1557); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Date 02/13/2017

Event Type  malfunction  

Event Description

Boxes of hot packs that are hard as bricks.The device was activated in shipping.

• Brand Name: HOT PACK MED 6 X 6.5
• Type of Device: HEEL WARMER
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.; 1500 waukegan rd; waukegan IL 60085
• MDR Report Key: 6363945
• MDR Text Key: 68502463
• Report Number: 6363945
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 11450-040
• Device Catalogue Number: 11450-040
• Device Lot Number: V6P261
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2017
• Device Age: 1 DY
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO