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 10/16/2016

Event Type  malfunction  

Manufacturer Narrative

Customer was contacted by email five times over a period of three weeks requesting she contact ameda, inc.To assist her in resolving this issue.Ameda did not have any other means of contacting the customer.The customer has not responded to the emails to seek a solution to this problem.Due to a lack of response by the customer, no product was returned to ameda and a replacement pump base was not sent to the customer.Therefore no visual inspection or investigation of the pump base could be conducted.

Event Description

Customer contacted ameda parent care online on (b)(6) 2016.She reports her ac adapter stopped functioning 1 month prior and since that time, she uses batteries to power on the purely yours breast pump she uses for pumping breast milk.Customer reports two batteries started to leak dark fluid from the battery compartment on 2 separate occasions the day before the complaint was sent to ameda, inc.At this time, it is unknown whether customer came in contact with the battery fluid.

• 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: 6100606
• MDR Text Key: 59882885
• Report Number: 3009974348-2016-00237
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K973501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• 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
• Date Manufacturer Received: 10/17/2016
• 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: 29 YR