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U.S. Department of Health and Human Services

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

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AMEDA, INC. 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 04/02/2019
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. There was very minor evidence (dark grey substance, e. G battery acid) observed inside the battery compartment and on battery cover. Internally, there were no indications of burning, melting or charring visible.

 
Event Description

Customer contacted ameda, inc. On (b)(6) 2019 regarding an incident that occurred that same day during usage of her purely yours breast pump on battery power. She had installed 6 new (b)(6) alkaline batteries in the pump base after forgetting her ac adapter at home that day. Customer states hearing a hissing noise coming from the base at the end of the pumping session. She stopped pumping, opened the battery compartment and noted dark fluid covering the batteries. One battery was damaged and leaking fluid. Customer reports no burn or injury since she waited until fluid cooled before removing batteries from base. Customer was shipped a replacement purely yours breast pump after this event.

 
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Brand NamePURELY YOURS
Type of DeviceELECTRIC BREAST PUMP
Manufacturer (Section D)
AMEDA, INC.
485 half day dr.
suite 320
buffalo grove IL 60089
Manufacturer Contact
linda zager
485 half day rd.
suite 320
buffalo grove, IL 60089
8479642620
MDR Report Key8562852
MDR Text Key147322816
Report Number3009974348-2019-00339
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 04/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/29/2019
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 Manufacturer04/29/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/02/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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