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U.S. Department of Health and Human Services

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

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AMEDA, INC. PURELY YOURS ULTRA ELECTRIC BREAST PUMP Back to Search Results
Model Number 24501879
Device Problem Fluid Leak (1250)
Patient Problem Burn(s) (1757)
Event Date 11/11/2018
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Customer contacted ameda, inc. On 01/14/2019 to report an incident in which new aa (b)(6) batteries leaked dark fluid inside the battery compartment of her purely yours ultra breast pump prior to pumping. This event occurred on (b)(6) 2018 while customer was preparing to pump in her car after work. She states hearing a fizzing sound inside the battery compartment and when she opened the compartment door she found batteries leaking dark fluid. She reports feeling panicked and grabbed the batteries to remove them. In the process, she burned her left middle finger with a hot battery. Customer reports the skin was red and irritated. She washed her hands in cold water and bandaged the middle finger to protect it; however, nothing was applied to the skin. A replacement purely yours ultra breast pump was overnight shipped to the customer.

 
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Brand NamePURELY YOURS ULTRA
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 Key8304931
MDR Text Key135002588
Report Number3009974348-2019-00335
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 01/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number24501879
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/18/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/05/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/05/2019 Patient Sequence Number: 1
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