MAUDE Adverse Event Report: CARDINAL HEALTH MOBERLY INFANT HEEL WARMER,SQUEEZE, 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number 11460-010T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 08/13/2017

Event Type  Injury  

Manufacturer Narrative

A device history record review was completed on the reported lot v7d106.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.During production, the formulation of the product is tested every 2 hours to measure the maximum temperature that it can generate.The tolerance for this process is 104.0 ± 1.8 ºf.Only if all samples meet this tolerance are they even released.Based on peak temperature upon activation, a burn is not likely with this product.Per astm standard c 1055-99e the lowest temperature where the epidermis damage occurs is at 111.2f and a burn is not likely with this product.(b)(4) samples were received by the site on 08/30/2017.Out of (b)(4) samples, (b)(4) samples were pre-activated while 50 samples were not.Site¿s qe tested the samples in an environmental chamber with an ambient temp of 75ºf.Max temp recorded was 104.8 ºf and a minimum of 103.1 ºf.No corrective action would be initiated for this complaint.Plant will keep monitoring the incoming complaints for this complaint mode for this product.

Event Description

Based on information received from the customer, the heel warmer was placed on the newborns heel, however, it allegedly burned the baby's skin on the right lateral ankle and caused a blister.The nurse immediately placed a clean cool cloth on the area.When the baby was seen by the pediatrician, he referred the infant to the burn unit.

• Brand Name: INFANT HEEL WARMER,SQUEEZE, 4X4IN
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer (Section G): CARDINAL HEALTH MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6847700
• MDR Text Key: 85095506
• Report Number: 1423537-2017-00124
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/07/2017

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: Nurse
• Device Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: V7D106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/14/2017
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other