BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 7639306 · Received June 26, 2018

    Report

    Report Number
    1419937-2018-00150
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    May 23, 2018
    Report Date
    June 26, 2018
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 06/12/2018, THE CUSTOMER INDICATED THAT SHE WAS DIAGNOSED WITH A YEAST INFECTION ON (B)(6) 2018, AND ON (B)(6) 2018, SHE INDICATED THAT SHE WAS PRESCRIBED AN ANTIBIOTIC FOR TREATMENT. SHE INDICATED THAT THE REPLACEMENT PUMP WAS WORKING BETTER, BUT SHE WAS STILL HAVING SOME NIPPLE PAIN AND FOLLOWING UP WITH HER DOCTOR AT THE END OF THE WEEK. BASED ON THIS, THE CUSTOMER WAS REFERRED TO MEDELA'S CLINICAL STAFF AND CONTACT WITH THE CUSTOMER IS ON-GOING. THE DEVICE WAS RETURNED WITHOUT THE CUSTOMER'S PARTS AND ACCESSORIES; THEREFORE, IT WAS EVALUATED WITH A MEDELA LAB KIT ON 06/26/2018 AND IT PASSED SUCTION AND CYCLE SPECIFICATIONS. REFER TO ATTACHED EVALUATION. THE CUSTOMER'S REPORT OF LOW SUCTION COULD NOT BE CONFIRMED. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S THRUSH. REPORTED ISSUES OF THRUSH WERE INVESTIGATED UNDER (B)(4) AND THE ROOT CAUSES WERE IDENTIFIED AS: (1) LACK OF EDUCATION/TRAINING TO MOTHERS ON BREAST FEEDING AND BREAST MILK PUMPING; (2) INSUFFICIENT GUIDANCE ON BREAST SHIELD SIZING TO PREVENT NIPPLE TRAUMA; (3) INSUFFICIENT PERSONAL HYGIENE PRACTICES PRIOR TO BREAST MILK PUMPING OR BREAST FEEDING; AND (4) NO ACCESS TO OR NOT FOLLOWING THE MANUFACTURES' INSTRUCTIONS FOR THE CLEANING AND SANITATION OF THE BREAST MILK PUMPING COMPONENTS. NO CORRECTIVE ACTIONS RESULTED AS IT WAS DETERMINED THAT DETAILED INSTRUCTIONS ARE AVAILABLE AND ADEQUATE IN BOTH PRINTED AND ON-LINE FORMATS FOR CLEANING BREAST MILK PUMPING EQUIPMENT, PERSONAL HYGIENE, PROPER BREAST SHIELD SIZING TO PREVENT NIPPLE SORENESS/TRAUMA, WHICH CAN LEAD TO SKIN BREACHES, ALLOWING FOR THE POTENTIAL INTRODUCTION OF YEAST.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SUCTION ON HER PUMP IN STYLE BREAST PUMP WAS LOW. SHE FURTHER ALLEGED THAT HER NIPPLES WERE HURTING AND SHE WENT TO HER DOCTOR, WHO THOUGHT SHE HAD A YEAST INFECTION, FOR WHICH SHE WAS PRESCRIBED A TOPICAL CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482442 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA LLC 57081 10442384

    Patients

    Seq Age Sex Outcome Treatment
    1 Other