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Adverse Event Report

EVENFLO PRODUCTS CO. EVEN FLO ELECTRIC BREAST PUMP   back to search results
Event Description

Lactation consultant has had approx six pts over a 2 yr period who have had excoriation and bruising of nipples with use of the electric breast pump. Comfort measures and cessation of pumping alleviated problem.

 
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Brand NameEVEN FLO
Type of DeviceELECTRIC BREAST PUMP
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
EVENFLO PRODUCTS CO.
1000 evenflo dr.
canton GA 30114
Device Event Key211664
MDR Report Key218240
Event Key204775
Report NumberMW1016100
Device Sequence Number1
Product CodeHGX
Report Source Voluntary
Report Date 04/08/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/1999
Is This An Adverse Event Report? No
Device Operator Lay User/Patient
Was Device Available For Evaluation? No
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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