MAUDE Adverse Event Report: PURELY YOURS; ELECTRICAL BREAST PUMP

Model Number 24502082

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

Customer had discarded her entire purely yours breast pump system in the trash after this event occurred in (b)(6) 2018.Therefore there will not be a product return for an evaluation to be conducted.

Event Description

Customer contacted ameda, inc.On 01/09/2019 to report an incident that occurred on (b)(6) 2018 when using her purely yours breast pump.She states this was the second time she used the pump to express milk.Customer had the ac adapter plugged into an electrical outlet in her home.She reports gray smoke was emitted from the wall socket/adapter connection after she powered on the pump.She reports no injury or smoke inhalation in this event.Customer reports discarding the entire breast pump in the trash the day the event occurred.

• Brand Name: PURELY YOURS
• Type of Device: ELECTRICAL BREAST PUMP
• Manufacturer Contact: linda zager ; 485 half day rd.; suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 8257782
• MDR Text Key: 133385860
• Report Number: 3009974348-2019-00333
• Device Sequence Number: 1
• Product Code: HGX
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24502082
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/17/2019
• 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: N
• Patient Sequence Number: 1
• Patient Age: 32 YR