MAUDE Adverse Event Report: PURELY YOURS ELECTRIC BREAST PUMP

Model Number 24502082

Device Problem Fluid Leak (1250)

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

Event Date 08/30/2018

Event Type  Malfunction  

Manufacturer Narrative

The returned purely yours pump was tested per ameda engineering protocol to determine whether the allegation of leaking fluid could be confirmed. It was assessed for indications of malfunction or thermal event. It was also assessed for functionality and met functional specifications. Internally, there were no indications of burning, melting or charring visible.

Event Description

Customer contacted ameda, inc. On (b)(6) 2018 regarding an incident that occurred 2 months before. Customer reports using her purely yours breast pump on battery power when she heard a pop inside the pump base where battery compartment is located. She states this occurred sometime in late (b)(6) 2018. She stopped pumping, opened the battery compartment and found one battery leaking dark fluid and appeared damaged. Customer removed the damaged battery, cleaned up the dark fluid from the compartment and continued to pump using only the ac adapter. She reports she did not burn or injure herself in this event. A replacement purely yours breast pump was overnight shipped to the customer.

• Brand Name: PURELY YOURS
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer Contact: linda zager ; 475 half day rd.; suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 8108485
• MDR Text Key: 129312205
• Report Number: 3009974348-2018-00328
• 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

• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 11/27/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: 24502082
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 11/16/2018

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 07/11/2018
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage