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 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

The returned purely yours breast pump was assessed for functionality and met functional specifications.There was no internal evidence to support the allegation of a malfunction or thermal event.Additional testing supports that the misplacement of a battery or batteries in the battery compartment can result in battery failure and/or leakage.

Event Description

Customer contacted ameda, inc.On 10/23/2018 to report the purely yours breast pump she was using the night before began having issues with function.Customer was using the pump on battery power at the time.She states often using batteries to power on her pump.She stopped pumping, opened the battery compartment door and found dark leaking fluid coming from one of the batteries.Customer removed the batteries from the compartment, coming in contact with leaking battery.She denied any burn or injury in this event.Customer was overnight shipped a replacement pump base.

• 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: 8034094
• MDR Text Key: 127886631
• Report Number: 3009974348-2018-00327
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• 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: 10/30/2018
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2018
• 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: 24 YR