BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 13733223 · Received March 11, 2022

    Report

    Report Number
    3002807523-2022-00002
    Event Type
    Injury
    Date Received
    March 11, 2022
    Date of Event
    August 1, 2021
    Report Date
    March 11, 2022
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    UDI-DI
    00020451379807
    PMA / PMN Number
    K191653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER BY VERIFYING THAT SHE DID NOT HAVE A MILK BACKUP, REQUESTED TO RESET THE BATTERY ON HER PUMP AND CHARGE IT FOR AN HOUR. THE CUSTOMER WAS ADVISED TO CONTACT MEDELA LLC BACK IF THAT DID NOT RESOLVE THE BATTERY CHARGING ISSUE WITH HER PUMP. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 02/24/2022, ON A DIFFERENT PUMP, THE CUSTOMER STATED THAT SHE HAD MASTITIS BACK IN (B)(6) FROM THE PUMP HAVING LOW SUCTION. SHE INDICATED THAT SHE HAD A BAD CASE OF MASTITIS IN AUGUST AND WAS SENT TO HAVE MAMMOGRAMS UNTIL IT CLEARED. IN FOLLOW UP AGAIN ON (B)(6) 2022, THE CUSTOMER STATED THAT SHE WAS PRESCRIBED ANTIBIOTICS. ADDITIONALLY, THE CUSTOMER STATED THAT SHE NEVER CALLED MEDELA TO REPORT IT. BASED ON THE RESULTS OF OUR INTERNAL INVESTIGATION (REFERENCE NUMBER (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 OF MASTITIS. RIORDAN & WAMBACH, 4TH ED. P. 294: BREASTFEEDING AND HUMAN LACTATION. HOWEVER IN THIS CASE, THE MOTHER¿S MASTITIS REQUIRED PROMPT MEDICAL ATTENTION FOR PAIN RELIEF AND PRESCRIPTION ANTIBIOTICS TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THE HER FREESTYLE FLEX BREAST PUMP WOULD SLOWLY DIE THROUGHOUT THE DAY AND NOW IT WILL NOT TURN ON AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38887 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 179389 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other