MAUDE Adverse Event Report: RAPID AID CORP.; INFANT HEEL WARMER

Catalog Number MDS138007

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

It was reported that a baby suffered a burn on their heel and big toe after placing an infant heel warmer on it.It is unknown how long it was in place.It is unknown if any medical treatment was provided.Minimal details were provided by the account.The sample has not been returned for evaluation.This device is manufactured by rapid aid corp.For medline.Rapid aid has been notified of this incident.We have not identified a root cause but due to the reported injury, this medwatch is being filed.

Event Description

A baby suffered a burn on their heel and big toe after placing an infant heel warmer on it.

• Type of Device: INFANT HEEL WARMER
• Manufacturer (Section D): RAPID AID CORP.; 4120a sladeview crescent; mississauga onl5l 5z3, canada
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5471813
• MDR Text Key: 39423595
• Report Number: 1417592-2016-00016
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2016

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 Catalogue Number: MDS138007
• Device Lot Number: RD12RAL
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/01/2016
• 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