MAUDE Adverse Event Report: AMEDA INC. PURELY YOURS; ELECTRIC BREAST PUMP, 884.5160

Model Number 24502082

Device Problem Device Handling Problem (3265)

Patient Problem Electric Shock (2554)

Event Date 01/03/2014

Event Type  malfunction  

Event Description

As part of ameda, inc.'s quality management system activities, a review of historical complaints was conducted.It was determined that this complaint should have been reported to fda.Customer contacted ameda, inc.On (b)(6) 2014 to report the ac adapter she uses to power on the purely yours breast pump has given her a shock when plugging it in.She reports the ac adapter casing had fallen off.Customer states she had wet hands when plugging in the ac adapter.Customer denied any injury, burn or property damage and did not seek any medical advice/treatment.

Manufacturer Narrative

Customer was sent a replacement ac adapter and purely yours breast pump base.She was instructed to return the ac adapter and breast pump back to ameda, inc.For testing, using the prepaid fedex label sent to her.Several attempts were made to contact customer to encourage product return.As of this date, the ac adapter and purely yours breast pump have not been returned to ameda, inc.For testing.

• Brand Name: PURELY YOURS
• Type of Device: ELECTRIC BREAST PUMP, 884.5160
• Manufacturer (Section D): AMEDA INC.; buffalo grove IL
• Manufacturer Contact: 485 half day rd ste 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 4943570
• MDR Text Key: 6254216
• Report Number: 3009974348-2015-00154
• 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: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• 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
• Date Manufacturer Received: 01/03/2014
• 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