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

Model Number 24502081

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 01/27/2015

Event Type  malfunction  

Event Description

A written report was received by ameda from the (b)(6) on an international product complaint form that a dual lactaline breast pump reportedly gave the user an electric shock.No injury was reported.

Manufacturer Narrative

The product has not been returned to ameda, inc for investigation at this time.

• Brand Name: LACTALINE
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA INC.; 485 e half day rd ste 320; buffalo grove IL 60089 000
• Manufacturer Contact: marsha nelson ; 485 half day rd ste 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 4602607
• MDR Text Key: 5470876
• Report Number: 3009974348-2015-00063
• 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: Other
• Type of Report: Initial
• Report Date: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24502081
• Device Lot Number: 4E028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other