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

Model Number 24501879

Device Problem Suction Problem (2170)

Patient Problem Unspecified Infection (1930)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

The returned product was evaluated for evidence of allegation and low suction was confirmed.The piston seal was torn and caused the low suction.

Event Description

Customer contacted ameda, inc.On 01/24/2017 to report the purely yours ultra breast pump she has been using for 3 months has decreased suction and diminished milk output leaving her breasts full.She reports feeling flu-like symptoms with fever and a sore, swollen left breast the night of (b)(6) 2017.Customer phoned her healthcare provider the following day, (b)(6) 2017 about her symptoms and was diagnosed with left breast mastitis.She was prescribed a 7 day course of oral antibiotics by her physician.The breast pump was replaced and mastitis improved over the next 2-3 days.

• Brand Name: PURELY YOURS ULTRA
• 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: 6329546
• MDR Text Key: 67379528
• Report Number: 3009974348-2017-00249
• 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: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 24501879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2015
• 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: 34 YR