MAUDE Adverse Event Report: COOPERSURGICAL, INC. INFANT HEEL WARMER / WARMGEL INFANT HEEL WARMER; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number REF 20418

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2017

Event Type  malfunction  

Event Description

Patient care technician (pct) was preparing the baby for lab work, when using the footwarmers the pct became instantly aware that the warmers were way too warm.She threw those away and got another one which worked fine.Potential for risk of burn to baby.

• Brand Name: INFANT HEEL WARMER / WARMGEL INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 7218146
• MDR Text Key: 98224997
• Report Number: 7218146
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2018

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: REF 20418
• Device Catalogue Number: 20418
• Device Lot Number: 920418-280001
• Other Device ID Number: (01)10017436204183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO