MAUDE Adverse Event Report: MEDELA AG FREESTYLE FLEX BREAST PUMP EN FR ES; PUMP, BREAST, POWERED

Model Number 101037980

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

Patient Problem Burn, Thermal (2530)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

There is no customer contact information so follow up with the customer cannot be performed.Medela is filing this report, which is considered a serious injury as it required medical attention (medical treatment was required).

Event Description

On (b)(6) 2020 the customer reported to fda (mw5097084) that her toddler had picked up her freestyle flex breast pump while it was plugged in and had immediately started screaming.She additionally alleged that he was burnt by the pump and that when she had taken it away from him it was hot and melting.He was taken to the doctor for treatment of a severe burn.

• Brand Name: FREESTYLE FLEX BREAST PUMP EN FR ES
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• Manufacturer Contact: mike mcandrew ; 1101 corporate dr; mchenry, il ; 4358316
• MDR Report Key: 10875191
• MDR Text Key: 217331535
• Report Number: 1419937-2020-00132
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451379807
• UDI-Public: 020451379807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101037980
• Device Catalogue Number: 101037980
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other