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

Model Number 24502082

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 07/16/2014

Event Type  Injury  

Event Description

Customer emailed ameda on (b)(6) 2014 reporting that one side of her dual electric breast pump is not working properly and gives her a shocking feeling during use.

Manufacturer Narrative

Three email messages were left at the customer's email address for the purpose of assessing for injury after customer reported a shock from the breast pump.To date, the customer has not returned any email messages.

• Brand Name: PURELY YOURS
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA INC.; buffalo grove IL
• Manufacturer (Section G): AMEDA INC.; 485 e half day rd ste 320; buffalo grove IL 60089 000
• Manufacturer Contact: 485 e half day rd ste 320; buffalo grove, IL 60089-0000
• MDR Report Key: 4726691
• MDR Text Key: 5581062
• Report Number: 3009974348-2015-00003
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• Is this an Adverse Event Report?: Yes
• 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
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other