BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSTEAD SOFTCUP

    MDR report key: 1198943 · Received September 25, 2008

    Report

    Report Number
    3026654-2008-00001
    Event Type
    Other
    Date Received
    September 25, 2008
    Date of Event
    August 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    INSTEAD HEALTHCARE, LLC
    Product Code
    HHE
    PMA / PMN Number
    K920792
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EMAILS CORRESPONDENCE TO CONSUMER: 09/03/2008. HI (B) (6), THANK YOU FOR SPEAKING WITH ME ON THE PHONE ABOUT YOUR EXPERIENCE WITH INSTEAD. PLEASE READ THE INFORMATION BELOW REGARDING THE DIAGNOSIS OF TSS. I COMPLETELY UNDERSTAND YOUR RELUCTANCE TO RELEASE MEDICAL RECORDS. IF YOU HAVE ANY FURTHER COMMENTS ABOUT YOUR EXPERIENCE OR FIND OUT ANY NEW INFORMATION REGARDING YOUR ILLNESS, PLEASE LET US KNOW. I HAVE COPIED OUR MEDICAL DIRECTOR, (B) (6). PLEASE FEEL FREE TO RESPOND WITH ANY QUESTIONS OR COMMENTS. AGAIN, I AM VERY SORRY FOR YOUR EXPERIENCE AND I APPRECIATE YOUR COOPERATION IN THIS MATTER. NO RESPONSE RECEIVED. 09/18/2008. HI (B) (6), I WANTED TO FOLLOW UP WITH YOU AGAIN ABOUT YOUR TSS DIAGNOSIS. WHEN WE LAST SPOKE YOU WERE AWAITING BLOOD TEST RESULTS AFTER A SECOND TRIP TO THE ER. DID THESE BLOOD TESTS CONFIRM YOUR ORIGINAL DIAGNOSIS OF TSS? WE ARE REQUIRED BY FDA LAW TO REPORT THESE TYPES OF COMPLAINTS ASSOCIATED WITH OUR PRODUCT TO THE FDA. IN ORDER TO COMPLY WITH FDA REGULATIONS, WE NEED A COPY OF THE MEDICAL RECORDS WHICH SHOW YOUR PHYSICIAN DIAGNOSIS OF TSS. IF TSS WAS IN FACT THE DIAGNOSIS, AND IT WAS AT ALL ASSOCIATED WITH CUP USE, WE NEED TO REPORT THIS TO THE FDA. NO RESPONSE RECEIVED.

    Description of Event or Problem · 1

    CUSTOMER WORE THE INSTEAD SOFTCUP FOR THE FIRST TIME ON (B) (6) FOR 8 HRS. THE NEXT DAY, SHE WORE IT FOR 3 HOURS. SHE HAD A SUDDEN CASE OF DIARRHEA AND FELT SWEATY AND FEVERISH WITH ALL OVER BODY ACHES. SHE SLEPT 3 HOURS, BUT STILL FELT UNCOMFORTABLE. ON SUNDAY, SHE FELT DISORIENTED AND FORGETFUL, HAZY AND DRUGGY. SHE WENT TO HER PHYSICIAN AND WAS DIAGNOSED WITH TSS AND WAS INSTRUCTED NOT TO USE THE CUP AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTEAD SOFTCUP MENSTRUAL CUP (HHE) HHE INSTEAD HEALTHCARE, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other