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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 10/30/2018
Event Type  Malfunction  
Manufacturer Narrative

The returned py pump was unable to be properly tested physical unit investigation revealed that the misplacement of a battery in the battery compartment resulted in battery failure and or leakage. Damaged battery contacts, suction dial and broken tubing port made investigation process difficult.

 
Event Description

Customer returned an older, formerly used purely yours breast pump to ameda, inc. By error. Upon investigating this pump, it was noted to have 6 aa sunbeam batteries inside battery compartment of pump base. At some point, these batteries leaked battery acid into the battery compartment possibly during past use or during the shipping process back to ameda. This pump is out of warranty.

 
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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 Key8130348
MDR Text Key129312389
Report Number3009974348-2018-00329
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 11/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/04/2018
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 Manufacturer11/02/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/04/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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