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 04/07/2018

Event Type  malfunction  

Manufacturer Narrative

The returned product was assessed for functionality and met functional specifications.Additional testing supports that the misplacement of a battery can cause battery leakage.

Event Description

Customer contacted ameda, inc.On (b)(6) 2018 to report an incident occurred while pumping using her purely yours breast pump on (b)(6) 2018.She states using batteries to power on the pump.Customer reports hearing a loud pop from inside the pump during pumping, she stopped pumping immediately and once home, she opened the battery compartment.She states silver fluid leaked out from the compartment onto her hands.She washed her hands well and states no burn or injury was involved in this event.Customer reports the batteries were damaged so she discarded them.

• Brand Name: PURELY YOURS
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA, INC.; 475 half day rd.; suite 320; buffalo grove IL 60089
• Manufacturer Contact: linda zager ; 475 half day rd.; suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 7488985
• MDR Text Key: 107573424
• Report Number: 3009974348-2018-00316
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2017
• 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: 32 YR