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 04/23/2016

Event Type  malfunction  

Manufacturer Narrative

Customer was emailed and phoned twice requesting return of the purely yours breast pump base to ameda, inc.For investigation of alleged leaking fluid.As of this date, 05/23/2016, the pump base has not been returned to ameda, therefore no visual inspection or testing could be conducted.

Event Description

Customer contacted ameda, inc.On (b)(6) 2016 to report batteries exploded and leaked battery fluid inside battery compartment of her purely yours breast pump during usage on (b)(6) 2016.Customer was pumping while traveling in the car when this event occurred.She denies any battery fluid leaking onto her therefore no injury or burn occurred.Replacement purely yours breast pump was shipped overnight to customer.

Manufacturer Narrative

The returned product was tested per ameda engineering protocol to determine whether the allegation of leaking fluid could be confirmed.The returned product was assessed for indications of malfunction or thermal event.The returned product was assessed for functionality and met functional specifications.Dark grey substance, e.G battery acid, was observed inside the battery compartment.Internally, no signs of foreign substance, burning, melting or charring were observed.Additional testing confirmed that batteries may leak when the upper middle battery is placed incorrectly, with the positive and negative end reversed.

• 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: 5673212
• MDR Text Key: 45699690
• Report Number: 3009974348-2016-00207
• 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: Patient
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2014
• 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: 31 YR