MAUDE Adverse Event Report: MEDELA LLC FREESTYLE FLEX; PUMP, BREAST, POWERED

Model Number I DON'T KNOW

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 10/01/2020

Event Type  Injury  

Event Description

I used my freestyle flex breast pump and left it plugged in on the table.My toddler grabbed the pump and started screaming.His hand was bright red and i found out that he got burnt by the pump because when i picked it up, it was very very hot and the plastic was even melting.I took him to the doctor for treatment of a severe burn.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE FLEX
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC
• MDR Report Key: 10634437
• MDR Text Key: 210204482
• Report Number: MW5097084
• Device Sequence Number: 1
• Product Code: HGX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: I DON'T KNOW
• Device Catalogue Number: I DON'T KNOW
• Device Lot Number: I DON'T KNOW
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR