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

Model Number 24502082

Device Problem Suction Problem (2170)

Patient Problems Feeding Problem (1850); Unspecified Infection (1930); Occlusion (1984)

Event Date 04/21/2014

Event Type  Injury  

Event Description

A 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 purely yours breast pump she uses has low suction and she is unable to express breast milk effectively.Customer exclusively pumps and does not nurse her baby.Customer developed engorgement and clogged milk ducts which eventually led to a breast infection.Customer was attended to at an emergencare facility last evening on (b)(6) 2014 with symptoms of mastitis.Customer was prescribed oral antibiotics for 7 days and rented a hospital grade breast pump which resolved the mastitis.

Manufacturer Narrative

Product was evaluated for evidence of allegation.The returned ameda purely yours breast pump met ameda specifications for both suction and speed, and passed visual inspection standards.No evidence of malfunction was observed.

• 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., suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 4864818
• MDR Text Key: 5845914
• Report Number: 3009974348-2015-00130
• 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: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• 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: 05/13/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other