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

Model Number 11460-010T

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

The device history record could not be reviewed since the lot number was not provided.No sample was provided for evaluation, therefore, the root cause could not be determined.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 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.No corrective action would be initiated for this complaint.The plant will continue monitoring the incoming complaints for this complaint mode for this product.

Event Description

Based on information received the infant heel warmer was activated and placed on the patients arm for a blood draw.A burn was later found on her skin.There was a fluid filled blister that later was flat and red and left intact.No treatment was provided.

• 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: 6600536
• MDR Text Key: 76259944
• Report Number: 1423537-2017-00097
• 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: Other
• Type of Report: Initial
• Report Date: 05/31/2017

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: No Information
• Device Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/08/2017
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 05/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 59