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

Model Number 24502082

Device Problem Power Problem (3010)

Patient Problem Intermenstrual Bleeding (2665)

Event Date 01/18/2015

Event Type  malfunction  

Event Description

The customer contacted ameda on (b)(6) 2015 to report receiving an electric shock when she connected the ac adapter into the wall outlet at her home.Customer states no injury occurred therefore she did not seek medical attention.

Manufacturer Narrative

The customer was shipped a replacement ac adapter on (b)(4) 2015.The used ac adapter was returned to ameda on 02/09/2015 and is currently being evaluated.A supplemental report will be filed.

• Brand Name: PURELY YURS
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA INC.; buffalo grove IL 60089 000
• Manufacturer Contact: 485 e half day rd ste 320; buffalo grove, IL 60089-0000 ; 8479642620
• MDR Report Key: 4638953
• MDR Text Key: 5601410
• Report Number: 3009974348-2015-00059
• 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: Risk Manager
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• 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?: Yes
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other