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

Catalog Number MDS138008

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient suffered a burn after the infant heel warmer was applied.We have not been able to confirm this reported injury or that it was a medline device.We have received very little information from the account regarding this incident.The extent of the injury or if any medical treatment was provided is unknown.No sample has been returned for evaluation.We tested the temperature after activation using retained samples of a different lot and all of the results were within specifications.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 and in an abundance of caution, this medwatch is being filed.

Event Description

It was reported that a patient suffered a burn after the infant heel warmer was applied.

• Type of Device: INFANT HEEL WARMER
• Manufacturer (Section D): RAPID AID CORP.; 4120a sladeview crescent; mississauga on l5l 5z3, canada
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5647059
• MDR Text Key: 44992619
• Report Number: 1417592-2016-00057
• 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: 05/11/2016

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: MDS138008
• Device Lot Number: CN152208A1
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/11/2016
• 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