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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

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MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE Back to Search Results
Model Number 57063
Event Date 02/16/2015
Event Type  Injury  
Event Description

The customer reported to customer service that her pump in style breast pump had low suction. She also reported that her doctor diagnosed her with a mastitis infection and prescribed her antibiotics.

 
Manufacturer Narrative

Medela customer service performed troubleshooting over the phone. The customer was unable to test the breast pump. Medela customer service requester her to call us back if pump issue persists. The medela clinician spoke to the customer on (b)(6) 2015, at which time the customer was able to reset the faceplate and her breast pump returned to normal operation. She also has fully recovered from the mastitis infection. Without report of continued symptoms, this issue is resolved with no permanent adverse effects to the customer. No further follow up necessary. "mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant. The risk of mastitis is higher among women who have breastfed previously, especially those with a history of mastitis. " ["breastfeeding and human lactation" (riordan & wambach, 4th ed. P. 294)] it cannot be definitively concluded that the pump caused or contributed to the customer's mastitis. Reported issues of mastitis are under investigation in (b)(4).

 
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Brand NamePUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
Manufacturer (Section D)
MEDELA, INC.
mchenry IL 60050
Manufacturer Contact
don alexander
1101 corporate dr.
mchenry , IL 60050
8004358316
MDR Report Key4580919
Report Number1419937-2015-00072
Device Sequence Number1
Product CodeHGX
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 02/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number57063
Device Catalogue Number57063
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Distributor Facility Aware Date02/16/2015
Date Manufacturer Received02/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/05/2015 Patient Sequence Number: 1
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