BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA DELUXE DOUBLE ELECTRIC BREASTPUMP SINGLE CAN

    MDR report key: 9460692 · Received December 12, 2019

    Report

    Report Number
    1419937-2019-00157
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    November 26, 2019
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K161725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED WITH THE CUSTOMER'S PARTS AND ACCESSORIES ON (B)(6)2020 TO MEDELA CANADA AND IT WAS SUBSEQUENTLY RETURNED TO MEDELA LLC (MANUFACTURER), WHO EVALUATED IT ON(B)(6)2020 . THE DEVICE PASSED SUCTION AND CYCLE SPECIFICATIONS WITH THE CUSTOMER'S RETURNED POWER SUPPLY. THOUGH DISCOLORATION AND RESIDUE (APPEARING TO BE OXIDIZATION) WAS FOUND ON THE POWER SUPPLY DC PLUG, IT DID NOT IMPACT THE SUCTION/CYCLE RESULTS. REFER TO ATTACHED PRODUCT EVALUATION AND PICTURES. THE CUSTOMER'S REPORT OF LOW SUCTION COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONTACTED MEDELA CANADA AGAIN ON 01/08/2020, ALLEGING HER SONATA BREAST PUMP WAS NOT SUCTIONING PROPERLY. SHE INDICATED THAT SHE WAS RENTING A MEDELA SYMPHONY BREAST PUMP BECAUSE OF THE ISSUES SHE HAD WITH THE SONATA PUMP, BUT WOULD NOW LIKE TO START USING IT AGAIN. MEDELA CANADA CUSTOMER SERVICE ASKED HER TO PROVIDE HER PROOF OF PURCHASE SO THEY COULD PROCEED WITH A RETURN OF THE ORIGINAL SONATA AND SEND A REPLACEMENT. ON 01/14/2020, THE CUSTOMER SENT IN HER PROOF OF PURCHASE. SHE WAS SENT A REPLACEMENT PUMP BY MEDELA CANADA AND THE RETURN OF HER ORIGINAL BREAST PUMP WAS REQUESTED FOR TESTING/EVALUATION. THE CUSTOMER WAS CONTACTED BY A COMPLAINT HANDLER TO CONFIRM THAT THE REPLACEMENT PUMP IS WORKING WELL FOR HER, WITH NO RESPONSE AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    MEDELA LLC CUSTOMER SERVICE ADVISED THE CUSTOMER TO CONTACT MEDELA CANADA CUSTOMER SERVICE FOR ASSISTANCE. AS OF THE DATE OF THIS REPORT, THE CUSTOMER HAS NOT CONTACTED MEDELA CANADA CUSTOMER SERVICE. THE COMPLAINT HANDLER ATTEMPTED TO CONTACT THE CUSTOMER BY EMAIL AT THE EMAIL ADDRESS SHE HAD PROVIDED TO MEDELA LLC CUSTOMER SERVICE, BUT IT WAS REJECTED AS AN INVALID EMAIL ADDRESS. ADDITIONALLY, A PHONE CALL ATTEMPT WAS MADE ON 12/11/2019, BUT THERE WAS NO ANSWER, SO A MESSAGE WAS LEFT BY THE COMPLAINT HANDLER REQUESTING ADDITIONAL INFORMATION. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION. BASED ON THE RESULTS OF CA11-001, 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. THE COMPLAINT RATE OF MASTITIS ACROSS ALL REPORTED FAILURES, ACROSS ALL MEDELA BREAST PUMPS, IS 0.008% FOR THE PERIOD OF (B)(6) 2013 TO (B)(6) 2017. 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) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SONATA BREAST PUMP HAD LOW SUCTION AND SHE DEVELOPED MASTITIS. SHE ADDITIONALLY ALLEGED THAT THE MASTITIS HAD TURNED INTO AN ABSCESS ON THE TOP OF HER NIPPLE, WHICH REQUIRED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251290 SONATA DELUXE DOUBLE ELECTRIC BREASTPUMP SINGLE CAN PUMP, BREAST, POWERED HGX MEDELA LLC 101033900 455559

    Patients

    Seq Age Sex Outcome Treatment
    1 Other