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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDELA INC. PUMP IN STYLE ADVANCED STARTER HGX

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MEDELA INC. PUMP IN STYLE ADVANCED STARTER HGX Back to Search Results
Model Number 57081
Device Problem Obstruction of Flow (2423)
Patient Problem Fungal Infection (2419)
Event Date 09/08/2015
Event Type  Injury  
Manufacturer Narrative

The customer was sent a replacement pump. It cannot be definitively concluded that the pump caused or contributed to the customer's thrush. Reported issues of thrush are under investigation in (b)(4). The product involved in the complaint was not returned for evaluation/investigation at this time. Therefore, no conclusions can be made as to the cause of the event. Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.

 
Event Description

The customer reported to customer service that she had milk backup into the motor of her pump in style advanced starter. The customer also stated that she has thrush and is taking nystatin and oral difflucan.

 
Manufacturer Narrative

The pump was returned to medela and evaluated on 10/07/2015, the evaluation showed that the pump passed all functional tests.

 
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Brand NamePUMP IN STYLE ADVANCED STARTER
Type of DeviceHGX
Manufacturer (Section D)
MEDELA INC.
1101 corporate dr.
mchenry IL 60050
Manufacturer (Section G)
MEDELA INC.
1101 corporate dr.
mchenry IL 60050
Manufacturer Contact
donald alexander
1101 corporate dr.
mchenry, IL 60050
8155782270
MDR Report Key5099137
MDR Text Key26595589
Report Number1419937-2015-00281
Device Sequence Number1
Product Code HGX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 09/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number57081
Device Catalogue Number57081
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/27/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/23/2015 Patient Sequence Number: 1
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