MAUDE Adverse Event Report: MEDLIN INDUSTRIES MEDLINE; INFANT HEEL WARMER

Model Number MDS138007

Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/08/2016

Event Type  Injury  

Event Description

Infant heel warmer was applied to heel after activation of warmer package.Package remained on baby's heel for 7-10min and when removed, the skin from heel was removed as well.Additionally, the great toe areas on plantar surface also had developed into fluid blister, that remained intact.Nursing states the package was discovered to have a small leak on the inner seam of the package.Nursing noted that all contents of the package were emptied out, as the substance had pooled at the bottom of area where it was applied.Dose or amount: one each.Frequency: as needed for labs.Route transdermal.Diagnosis or reason for use: to promote circulation of blood for lab draw.

• Brand Name: MEDLINE
• Type of Device: INFANT HEEL WARMER
• Manufacturer (Section D): MEDLIN INDUSTRIES; mundelein IL 60060
• MDR Report Key: 5462958
• MDR Text Key: 39218059
• Report Number: MW5060530
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 10080196719655
• UDI-Public: (01)10080196719655
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2016

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?: No
• Device Operator: No Information
• Device Model Number: MDS138007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 238 DA
• Patient Weight: 2