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

Model Number 24502082

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Customer no longer has the purely yours breast pump in her possession so was unable to return this pump to ameda for investigation.She discarded the pump base in the trash after the leaking fluid event occurred so this pump will never be returned for testing.Therefore a supplemental medwatch will not be sent at a later date.

Event Description

Customer contacted ameda, inc.On (b)(6) 2018 to report 6 aa batteries began leaking fluid from the battery compartment of her purely yours breast pump that morning while she pumped.She states using the same 6 aa batteries for at least 1 week pumping 5 times/day.She reports hearing a gurgling sound from the base prior to noting battery fluid leaking.Customer states she did not come in contact with the leaking fluid and was not harmed.She discarded the pump base in the trash after this event.A replacement purely yours pump was shipped overnight to the customer.

• 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: 7664480
• MDR Text Key: 113518199
• Report Number: 3009974348-2018-00321
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00810725021477
• UDI-Public: (01)00810725021477(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: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2016
• 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: 29 YR