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 06/30/2018

Event Type  malfunction  

Manufacturer Narrative

The returned purely yours pump was tested per ameda engineering protocol to determine whether the allegation of leaking fluid could be confirmed.It was assessed for indications of malfunction or thermal event.It was also assessed for functionality and met functional specifications.

Event Description

Customer contacted ameda, inc.On (b)(6) 2018 to report that while using 6 aa batteries to power on her purely yours breast pump 2 weeks ago, she heard a strange gurgling sound followed by clear bluish fluid that leaked from the battery compartment onto her hands.She states the fluid was warm and her hands tingled but she did not get burned or injured.She states no redness or blisters occurred.Customer did not seek medical attention after the event.She had pumped one other time with the same batteries before this event occurred.A replacement breast pump was shipped overnight to the 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: 7781269
• MDR Text Key: 117446422
• Report Number: 3009974348-2018-00324
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• 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: 07/30/2018
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2017
• 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 Age: 23 YR