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 12/29/2018

Event Type  malfunction  

Manufacturer Narrative

The customer discarded the purely yours pump base after the incident of leaking battery fluid from the 6 aa alkaline batteries in the pump base.Therefore the pump could not be investigated to determine the root cause of leaking battery fluid.A replacement purely yours breast pump was overnight shipped to the customer.

Event Description

Customer contacted ameda, inc.On 05/31/2019 to report an incident which occurred 6 months prior to this date while using her purely yours breast pump.She states that while using her pump on battery power, she experienced a large volume of battery acid leakage that extended to the outside of the battery compartment.Customer states touching the fluid accidentally however she was able to wash her hands immediately.No injury or burn occurred in this event.Customer discarded the pump base after this occurrence and called ameda 6 months later after speaking with her insurance company.A replacement purely yours breast pump was shipped to 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: 8727594
• MDR Text Key: 207335963
• Report Number: 3009974348-2019-00342
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/31/2019

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?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/24/2019
• 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: 40 YR