BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 7312543 · Received March 5, 2018

    Report

    Report Number
    1419937-2018-00058
    Event Type
    Injury
    Date Received
    March 5, 2018
    Date of Event
    February 22, 2018
    Report Date
    April 5, 2018
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. A MEDELA CLINICIAN FOLLOWED UP WITH THE CUSTOMER ON (B)(6) 2018, SHE INDICATED THAT THE REPLACEMENT PUMP WAS WORKING WITHOUT ISSUE AND SHE IS NO LONGER HAVING PAIN OR DISCOMFORT WITH PUMPING USING 30 MM PUMPING' PAL FLANGES THAT SHE PURCHASED ON HER OWN. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITHOUT THE CUSTOMER'S PARTS AND ACCESSORIES; THEREFORE, IT WAS EVALUATED WITH A MEDELA LAB KIT ON 03/23/2018 AND IT PASSED SUCTION AND CYCLE SPECIFICATIONS. IT WAS NOTED IN THE EVALUATION THAT THE PUMP DID HAVE AN ABNORMAL NOISE. REFER TO ATTACHED EVALUATION. THE CUSTOMER'S COMPLAINT OF LOW SUCTION COULD NOT BE CONFIRMED. [(B)(4)].

    Description of Event or Problem · 1

    OM (B)(6) 2018 THE CUSTOMER ALLEGED TO MEDELA LLC THAT WHEN SHE TURNS ON HER PUMP IN STYLE BREAST PUMP, THE SUCTION IS FAST AND HARD, CAUSING HER PAIN. SHE VISITED A DOCTOR FOR THE PAIN AND WAS PRESCRIBED NEWMAN'S ORIGINAL MULTI PURPOSE CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157242 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA LLC 57081 439891

    Patients

    Seq Age Sex Outcome Treatment
    1 Other