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

Model Number 24501879

Device Problem Fluid/Blood Leak (1250)

Patient Problem Burn(s) (1757)

Event Date 11/11/2018

Event Type  Injury  

Manufacturer Narrative

The returned purely yours ultra 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 01/14/2019 to report an incident in which new aa (b)(6) batteries leaked dark fluid inside the battery compartment of her purely yours ultra breast pump prior to pumping.This event occurred on (b)(6) 2018 while customer was preparing to pump in her car after work.She states hearing a fizzing sound inside the battery compartment and when she opened the compartment door she found batteries leaking dark fluid.She reports feeling panicked and grabbed the batteries to remove them.In the process, she burned her left middle finger with a hot battery.Customer reports the skin was red and irritated.She washed her hands in cold water and bandaged the middle finger to protect it; however, nothing was applied to the skin.A replacement purely yours ultra breast pump was overnight shipped to the customer.

• Brand Name: PURELY YOURS ULTRA
• 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: 8304931
• MDR Text Key: 135002588
• Report Number: 3009974348-2019-00335
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 0081072501484
• UDI-Public: (01)0081072501484(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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 24501879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2017
• 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 Outcome(s): Other
• Patient Age: 29 YR