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

Model Number 24502082

Device Problem Suction Problem (2170)

Patient Problem Unspecified Infection (1930)

Event Date 01/28/2016

Event Type  Injury  

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.

Event Description

Customer contacted ameda, inc.On (b)(6) 2016 to report the purely yours breast pump she uses to express milk for her infant starting losing suction, leading to decreased milk output and poorly drained breasts on (b)(6) 2016.She was diagnosed with right breast mastitis on (b)(6) 2016 by an urgentcare physician.Customer was prescribed a 10 day course of oral antibiotics by her healthcare provider on (b)(6) 2016 with good resolution of the symptoms in 3 days.

• 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: 5504343
• MDR Text Key: 40476933
• Report Number: 3009974348-2016-00198
• 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: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2015
• 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: 28 YR