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 12/15/2017

Event Type  Injury  

Manufacturer Narrative

Customer was emailed and phoned three times requesting return of the purely yours breast pump base for investigation after she was shipped a replacement pump base the day of the complaint.Customer has not returned the pump base therefore no visual inspection or investigation was conducted.A supplemental medwatch report will be submitted once the product is returned and investigation complete.

Event Description

Customer contacted ameda, inc.On (b)(6) 2017 to report her ameda purely yours breast pump has not been functioning properly in the past several weeks with decreased suction and milk output.She states experiencing less suction and milk output.Customer reports the pump sounds louder and knocking is heard that wasn't present prior to the issue.Customer states that decreased suction and milk output led to the mastitis infection she was diagnosed with on (b)(6) 2017.She was examined by her healthcare professional, prescribed oral antibiotics and ameda replaced her purely yours breast pump.

Manufacturer Narrative

The returned product was evaluated for evidence of allegation.The returned (b)(4) breast pump met (b)(4) 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
• 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: 7201085
• MDR Text Key: 97575436
• Report Number: 3009974348-2018-00306
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00810725021477
• UDI-Public: (01)00810725021477(21)
• 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,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• 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: 01/24/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2017
• 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: 32 YR