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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 02/19/2019
Event Type  Malfunction  
Manufacturer Narrative

The returned purely yours breast pump was assessed for functionality and met functional specifications. There was no internal evidence to support the allegation of a pump malfunction or thermal event. Evidence supports that the misplacement of a battery in the battery compartment resulted in battery failure/leakage.

 
Event Description

Customer contacted ameda, inc. On (b)(6) 2019 to report the ameda ac adapter prong broke off where it inserts into the electrical outlet. She was speaking with the ameda parent care representative to report this event. She was instructed to install 6 new aa alkalne batteries into the battery compartment of the purely yours pump base to test pump on battery power. She could then operate the pump on batteries as she waited for the shipment of a replacement ac adapter. While pumping on battery power, user reported the pump suddenly stopped operating and she heard a hissing sound from inside the pump base. Customer looked inside the battery compartment to find some batteries leaking dark fluid. The fluid stayed confined to the compartment. She denied any burn or injury when this event occurred. Customer was overnight shipped a replacement ac adapter and purely yours breast pump base.

 
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Brand NamePURELY YOURS
Type of DeviceELECTRIC 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 Key8378328
MDR Text Key138134806
Report Number3009974348-2019-00337
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 02/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/28/2019
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 Manufacturer02/26/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/13/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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