BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 7116549 · Received December 14, 2017

    Report

    Report Number
    1419937-2017-00350
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    October 13, 2017
    Report Date
    January 10, 2018
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S DEVICE WAS RETURNED WITHOUT THE CUSTOMER'S PARTS AND ACCESSORIES. THE DEVICE WAS EVALUATED USING LAB PARTS AND ACCESSORIES AND PASSED ALL VACUUM AND CYCLE TESTING. REFER TO ATTACHED EVALUATION.

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2017, THE CUSTOMER STATED THAT SHE DEVELOPED MASTITIS FROM THE PUMP NOT EMPTYING HER BREAST, FOR WHICH SHE WAS PRESCRIBED PAIN MEDICATION. BASED ON THE RESULTS OF (B)(4), IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S MASTITIS. THE ESTIMATED INCIDENCE OF MASTITIS IN LACTATING WOMEN, WHETHER USING A BREAST PUMP OR NOT, ACCORDING TO PUBLISHED CLINICAL LITERATURE CAN BE AS HIGH AS 33%. IN FACT, CLINICAL GUIDELINES SUGGEST THE USE OF A BREAST PUMP TO FACILITATE WITHDRAWAL OF BREAST MILK DURING BOUTS OF MASTITIS. (B)(4). "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 OR MASTITIS." RIORDAN & WAMBACH, 4TH ED. P. 294: BREASTFEEDING AND HUMAN LACTATION. MASTITIS REQUIRES PROMPT MEDICAL ATTENTION FOR THE MOTHER FOR PAIN RELIEF AND PRESCRIPTION ANTIBIOTICS TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT HER PUMP IN STYLE BREAST PUMP "HAS A BAD MOTOR" AND THAT SHE COMPLETED ALL OF THE TROUBLESHOOTING ON THE WEBSITE, AS WELL AS PURCHASED ALL NEW PARTS, BUT THE PUMP STILL COULD NOT GET ALL OF THE MILK OUT OF HER BREAST. SHE ALLEGED THAT WHEN SHE TURNS IT ALL OF THE WAY UP, IT BARELY PULLS THE NIPPLE IN AND SHE HAS TO PHYSICALLY SQUEEZE HER BREAST WHILE PUMPING, WHICH IS INCONVENIENT AND PAINFUL. THE CUSTOMER WAS PROVIDED WITH TROUBLESHOOTING TIPS IN AN EMAIL RESPONSE. ON (B)(6) 2017, THE CUSTOMER PHONED IN, ALLEGING THAT SHE CONDUCTED ALL OF THE TROUBLESHOOTING TIPS PROVIDED, BUT THE SUCTION ON HER PUMP WAS STILL LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898069 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA LLC 57081 434990

    Patients

    Seq Age Sex Outcome Treatment
    1 Other