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

Model Number 20418

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

Heel warmers are creating heat that exceeds 104 degrees f.Temp has been registering at 110 degrees and above.

Manufacturer Narrative

(b)(4).

• Brand Name: WARMGEL
• 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: 4436494
• MDR Text Key: 17262637
• Report Number: 1216677-2015-00001
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20418
• Device Catalogue Number: 20418
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2014
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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