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

Model Number 24502082

Device Problem Failure to Shut Off (2939)

Patient Problem Unspecified Infection (1930)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

Customer was contacted by email and phone three times over several weeks requesting product return for investigation.As of this date, customer has made no attempt to contact ameda, inc.Or return the pump motor base for testing.If product should be returned to ameda for investigation at a later date, a supplemental medwatch will be filed.

Event Description

Customer contacted ameda, inc.On (b)(6) 2016 to report single pumping her right breast on (b)(6) 2016 with the ameda purely yours breast pump.She had the suction pressure set on medium.Customer reports the pump suddenly would not release pressure on her right breast and the sound of the motor was one of only suction without pause for approximately 30-60 seconds.She attempted to turn pump off by turning the suction dial to off position.Pump did not turn off.Customer pulled the ac adapter out of the base port which released suction on the breast.She states right nipple soreness and swelling with breast becoming engorged due to being unable to nurse or pump.Customer reports consulting with her healthcare provider on (b)(6) 2016 due to fever, red and sore right breast.She was diagnosed with mastitis amd prescribed antibiotics for 1 week.She states breast pain, nipple swelling and infection resolved in 2 days, so she could resume breastfeeding and pumping.

• Brand Name: PURELY YOURS
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA, INC.; 485 half day rd.; suite 320; buffalo grove IL 60089
• Manufacturer Contact: linda zager ; 485 half day rd.; suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 6131897
• MDR Text Key: 61019838
• Report Number: 3009974348-2016-00233
• 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: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 24502082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR