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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PURELY YOURS ELECTRIC BREAST PUMP

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PURELY YOURS ELECTRIC BREAST PUMP Back to Search Results
Model Number 24502082
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2018
Event Type  Malfunction  
Manufacturer Narrative

The returned purely yours pump was tested per ameda engineering protocol to determine whether the allegation of leaking fluid could be confirmed. It was assessed for indications of malfunction or thermal event. It was also assessed for functionality and met functional specifications. Internally, there were no indications of burning, melting or charring visible.

 
Event Description

Customer contacted ameda, inc. On (b)(6) 2018 regarding an incident that occurred 2 months before. Customer reports using her purely yours breast pump on battery power when she heard a pop inside the pump base where battery compartment is located. She states this occurred sometime in late (b)(6) 2018. She stopped pumping, opened the battery compartment and found one battery leaking dark fluid and appeared damaged. Customer removed the damaged battery, cleaned up the dark fluid from the compartment and continued to pump using only the ac adapter. She reports she did not burn or injure herself in this event. A replacement purely yours breast pump was overnight shipped to the customer.

 
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Brand NamePURELY YOURS
Type of DeviceELECTRIC BREAST PUMP
Manufacturer Contact
linda zager
475 half day rd.
suite 320
buffalo grove, IL 60089
8479642620
MDR Report Key8108485
MDR Text Key129312205
Report Number3009974348-2018-00328
Device Sequence Number1
Product Code HGX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK973501
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 10/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number24502082
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/16/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/11/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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