MAUDE Adverse Event Report: AMEDA.INC. PURELY YOURS; ELECTRIC BREAST PUMP

Model Number 24502082

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 09/23/2018

Event Type  Injury  

Manufacturer Narrative

Customer discarded the ac adapter immediately after this event.Therefore there will not be product returned to conduct an investigation as to the root cause of the ac adapter sparking and erupting in flames.

Event Description

Customer contacted ameda, inc.On (b)(6) 2019 to report her purely yours breast pump no longer powers on using batteries.She states she has been using batteries exclusively for 2 months since the ac adapter sparked and caught on fire in the electrical outlet she uses in her bedroom.This event occurred in late (b)(6) 2018.She turned off the pump and her significant other managed to pull the ac adapter out of the outlet.However the tip of 2 fingers and the side of his left hand were burned.He reported minor irritation, redness and a few blisters.He did not see a healthcare provider for this minor burn but took steps to perform his own first aid.He washed under cool water, placed neosporin ointment on burns and a bandage over the ointment.Customer discarded the charred ac adapter in the trash after this event.A replacement ac adapter and pump base were shipped overnight.

• Brand Name: PURELY YOURS
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA.INC.; 485 half day rd.; suite 320; buffalo grove IL 60089
• Manufacturer Contact: linda zager ; 485 half day rd.; suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 8258848
• MDR Text Key: 133459114
• Report Number: 3009974348-2019-00332
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 0081072501477
• UDI-Public: (01)0081072501477(21)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24502082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR