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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 24502082
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2019
Event Type  Malfunction  
Manufacturer Narrative

Damage from a battery malfunction due to the misplacement of a battery or batteries in the battery compartment as well as leaving batteries in pump unit after pumping session, which resulted in battery failure and or leakage, causing damage to pump unit.

 
Event Description

Customer contacted ameda, inc. On (b)(6) 2019 to report an incident that occurred that same day while she was pumping with the purely yours ultra breast pump. Pump is 4 years old and out of warranty. She described the ameda ac adapter stopped functioning recently so she uses batteries to power on the pump. Customer reports pumping at home when she heard an abnormal sound from within the battery compartment followed by dark fluid leaking from the compartment. She denies coming in contact with this leaking fluid from the batteries. She states some of the batteries were damaged. A replacement purely yours ultra breast pump and ac adapter were shipped to 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 Key9533493
MDR Text Key198554745
Report Number3009974348-2019-00347
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 12/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2019
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 Manufacturer12/16/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/11/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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