MAUDE Adverse Event Report: COOPERSURGICAL, INC. MEDISAFE INFANT HEEL WARMER

Model Number 24648

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 01/02/2008

Event Type  Injury  

Event Description

Patient suffered severe burns to his heel and calf and it is alleged that burn occurred at (b)(6) hospital.Coopersurgical product surveillance became aware of the event on (b)(6) 2014.

Manufacturer Narrative

E-complaint #(b)(4).Coopersurgical inc.Is currently investigating the reported complaint condition.A final report will be filed after customer follow up and investigation is complete.

• Brand Name: MEDISAFE INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER
• Manufacturer (Section D): COOPERSURGICAL, INC.; trumbull CT
• Manufacturer Contact: nana banafo ; 75 corporate dr.; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 4218758
• MDR Text Key: 20126445
• Report Number: 1216677-2014-00016
• Device Sequence Number: 1
• Product Code: MPO
• 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,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/29/2014

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: Health Professional
• Device Model Number: 24648
• Device Catalogue Number: 24648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2014
• Initial Date FDA Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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