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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMEDA, INC. PURELY YOURS; ELECTRIC BREAST PUMP, 884.5160
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AMEDA, INC. PURELY YOURS; ELECTRIC BREAST PUMP, 884.5160 Back to Search Results
Model Number 24502082
Device Problem Power Problem (3010)
Patient Problem Electric Shock (2554)
Event Date 11/15/2013
Event Type  malfunction  
Event Description
As part of ameda, inc.'s quality management system activities, a review of historical complaints was conducted.It was determined that this complaint should have been reported to fda.Customer contacted ameda, inc.On (b)(6) 2013 to report a shock sensation upon plugging in the ac adapter knowing the ac adapter wires were exposed.Customer reports no injury or burn.She did not seek medical attention in this matter.Purely yours pump and ac adapter were out of warranty, however ameda, inc.Replaced the ac adapter for this customer.
 
Manufacturer Narrative
Though requested, the reported product was not returned, therefore, no visual inspection and no functional testing could be performed.
 
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Brand Name
PURELY YOURS
Type of Device
ELECTRIC BREAST PUMP, 884.5160
Manufacturer (Section D)
AMEDA, INC.
buffalo grove IL
Manufacturer Contact
485 half day rd ste 320
buffalo grove, IL 
8479642620
MDR Report Key4943578
MDR Text Key6254218
Report Number3009974348-2015-00152
Device Sequence Number1
Product Code HGX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K973501
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Remedial Action Replace
Type of Report Initial
Report Date 11/15/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number24502082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/15/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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