BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMPLISSE

    MDR report key: 2222577 · Received August 16, 2011

    Report

    Report Number
    3008138005-2011-00003
    Event Type
    Other
    Date Received
    August 16, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 15, 2011
    Manufacturer
    SIMPLISSE INC.
    Product Code
    HGY
    PMA / PMN Number
    K093648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, CS1 CALLED CASE (B)(6) AND INFORMED HER THAT THE PUMP MUST BE RETURNED TO REVIEW FOR ELECTRICAL ISSUES. CS1 EXPLAINED TO CASE (B)(6) THAT IF THERE IS SOMETHING FUNCTIONALLY WRONG WITH THE PUMP HER MONEY WOULD BE REFUNDED. CASE (B)(6) STATED THAT WAS NOT ACCEPTABLE AND THAT SHE NEEDS A REFUND, REGARDLESS. CS1 QUESTIONED CASE (B)(6) REGARDING HER LACK OF CONTACTING CUSTOMER SERVICE FOR ASSISTANCE IMMEDIATELY. CASE (B)(6) STATED THAT SHE WAS STRESSED AT THE TIME AND HER MAIN CONCERN WAS TO GET MILK FOR HER BABY. THE BABY'S PEDIATRICIAN SUGGESTED THAT SHE GET A NIPPLE SHIELD TO HELP WITH THE PAIN/SHOCK SHE FELT. NO INFO IS AVAILABLE AS TO WHEN OR FOR WHAT PURPOSE CASE (B)(6) VISITED THE PEDIATRICIAN. CASE (B)(6) WAS UNABLE TO LOCATE A NIPPLE SHIELD AS DIRECTED BY THE PEDIATRICIAN AND DECIDED TO GO TO THE HOSPITAL WHERE THE BABY WAS BORN FOR ASSISTANCE WITH BREASTFEEDING. CASE (B)(6) STATED SHE DID NOT GO TO THE HOSPITAL WITH THE INTENT OF GETTING A DIFFERENT BRAND OF PUMP, JUST TO GET HER BABY FED. CASE (B)(6) WENT (B)(6) 2011 TO THE HOSPITAL TO SEE THE (B)(6). ON (B)(4) 2011, REFUND APPROVED BY ADMINISTRATOR. CASE (B)(6) WAS SO NOTIFIED AND SHE WILL RETURN THE PUMP FOR ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2011 CASE (B)(6) CALLED CUSTOMER SERVICE, SPOKE TO CS2, AND REPORTED THAT SHE IS UNABLE TO EXPRESS MILK WITH THE SIMPLISSE BREAST PUMP. CASE (B)(6) STATED THAT IT WAS PAINFUL TO USE THE DEVICE AND SHE FELT ELECTRICAL SHOCKS DURING USE OF THE DEVICE. ON (B)(4) 2011 CS1 SPOKE TO CASE (B)(6) AND VERIFIED THAT CASE (B)(6) CLAIMED TO FEEL ELECTRICAL CURRENT WHEN USING THE SIMPLISSE DOUBLE ELECTRIC BREAST PUMP. CASE (B)(6) REITERATED THAT BESIDES THE ELECTRICAL ISSUE SHE WAS NOT ABLE TO EXPRESS WITH THE SIMPLISSE PUMP. SHE TOOK THE PUMP TO A LACTATION CONSULTANT AT THE HOSPITAL BECAUSE OF THE ELECTRICAL CURRENT ISSUE, WHERE THE LC HAD CASE (B)(6) USE A MEDELA HOSPITAL-GRADE BREAST PUMP. THE HOSPITAL-GRADE PUMP IS WORKING WELL FOR CASE (B)(6) AND SHE IS HAVING NO ISSUE EXPRESSING MILK. SHE IS UNWILLING TO USE A REPLACEMENT SIMPLISSE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLISSE DOUBLE ELECTRIC BREAST PUMP HGY SIMPLISSE INC. S1005 SP 010131

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other