BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVENFLO FEEDING INC.

    MDR report key: 5501611 · Received March 15, 2016

    Report

    Report Number
    3009826814-0216-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    January 25, 2016
    Report Date
    February 22, 2016
    Manufacturer
    EVENFLO FEEDING INC.
    Product Code
    HGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENFLO ASSESSED THIS REPORT BASED ON THE CONSUMER-PROVIDED INFORMATION ALONE, AS THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR FURTHER INVESTIGATION. ACCORDINGLY, THE COMPANY IS UNABLE TO DETERMINE IF THE PRODUCT WAS OPERATING WITHIN SPECIFICATION OR SIMPLY DID NOT MEET THE CONSUMER'S EXPECTATIONS FOR VACUUM. NOTWITHSTANDING THE LACK OF INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED, EVENFLO IS NOTIFYING THE FDA BECAUSE THE AVAILABLE INFORMATION REASONABLY SUGGESTS THAT A REPORTABLE EVENT HAS OCCURRED. THE CONSUMER DEVELOPED MASTITIS DURING THE TIMEFRAME SHE WAS USING THE PUMP AND WAS SUBSEQUENTLY TREATED WITH ANTIBIOTICS, ALTHOUGH WHETHER THE PUMP CAUSED OR CONTRIBUTED TO THE CONDITION IS UNDETERMINED. MASTITIS IS USUALLY A BENIGN AND SELF-LIMITING INFECTION, BUT WHEN ANTIBIOTICS ARE NEEDED TO TREAT THE CONDITION THE POTENTIAL FOR PERMANENT INJURY IS PRESENT. THE COMPANY LEARNED FROM THE CONSUMER THAT SHE ALLEGEDLY HAD ENGORGEMENT PRIOR TO DEVELOPING MASTITIS. ENGORGEMENT IS NOT UNUSUAL IN WOMEN WHO BREASTFEED OR USE AN ELECTRIC PUMP AND IS A TEMPORARY CONDITION IN THE VAST MAJORITY OF INSTANCES, RELIEVED VIA BREASTFEEDING, HAND EXPRESSION OR OTHER AVAILABLE PUMPING DEVICE. FAILURE TO RELIEVE THE ENGORGEMENT WITH ONE OF THESE METHODS MAY HAVE CAUSED THE DEVELOPMENT OF MASTITIS AS WELL. MOREOVER, IF THE CONSUMER WAS DISSATISFIED WITH THE LEVEL OF VACUUM ON THE PUMP, IT IS REASONABLE TO EXPECT HER TO DISCONTINUE USE. EVENFLO DOES NOT HAVE INFORMATION TO SUGGEST THAT A MALFUNCTION OF THE PUMP LED TO THE MASTITIS, BUT THE MEDICAL INTERVENTION AND USE OF ANTIBIOTICS RENDERED THE EVENT REPORTABLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION TO THIS REPORT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2016, THAT HER ADVANCED DOUBLE ELECTRIC BREAST PUMP WOULD NOT GENERATE A VACUUM LEVEL SUITABLE FOR MILK EXPRESSION. THE CUSTOMER REPORTED THAT SHE HAS DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC BY HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156470 EVENFLO FEEDING INC. ADVANCED DOUBLE ELECTRIC BREAST PUMP HGX EVENFLO FEEDING INC. 516511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other