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

Model Number 101037980

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

Patient Problem Burn, Thermal (2530)

Event Date 09/02/2020

Event Type  Injury  

Event Description

Severe burn on finger; i was using my new medela freestyle flex double breast pump and when i went to unplug the usb cord from the pump, i burned my finger.After looking at it closely, i saw that the usb connector and the pump were badly melted and were very hot.I went online to look at product reviews and also to see if there have been other filings with the fda and see that there are quite a few customers who have experienced a similar melting.What is medela doing about this? i am afraid to think what might have happened if my baby grabbed the pump instead of me.This is unacceptable that medela is aware of this situation but appear to be doing nothing about it.I don't see anything to suggest that they have initiated a recall.Fda safety report id# (b)(4).

• Brand Name: MEDELA FREESTYLE FLEX DOUBLE BREAST PUMP
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC.
• MDR Report Key: 10634390
• MDR Text Key: 210196505
• Report Number: MW5097081
• 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
• 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: Lay User/Patient
• Device Model Number: 101037980
• Device Catalogue Number: 101037980
• 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: 31 YR