BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINX

    MDR report key: 16562710 · Received March 17, 2023

    Report

    Report Number
    3013407123-2023-00007
    Event Type
    Injury
    Date Received
    March 17, 2023
    Report Date
    April 3, 2023
    Manufacturer
    THINX, INC.
    Product Code
    NUQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION IS AVAILABLE REGARDING THE ALLEGED EVENT. THE INVESTIGATION CONCLUDED THERE WERE NO PRODUCT DEFECTS OR NONCONFORMANCES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE AND ITS COMPONENTS HAVE BEEN EVALUATED AND DETERMINED TO BE SAFE FOR THEIR INTENDED USE. OUR INVESTIGATION REVEALED NO BASIS TO CONCLUDE THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 C.F.R. PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION OR ADMISSION BY THINX, OR ITS EMPLOYEES, THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT, OR THAT THE THINX PRODUCT FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED. THIS INITIAL REPORT IS BASED ON INFORMATION WHICH THINX RECEIVED FROM THE CONSUMER; BUT THINX IS CONTINUING TO INVESTIGATE, AND THE INFORMATION HAS NOT BEEN FULLY VERIFIED. THE CONSUMER ALLEGES SERIOUS INJURIES; HOWEVER, NO DETAILS REGARDING THE REPORTED EVENT HAVE BEEN PROVIDED AND ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION CONTINUE. NO LOT INFORMATION WAS PROVIDED WITH THE COMPLAINT; HOWEVER, MANUFACTURING RECORDS ARE BEING REVIEWED BASED ON DATE RANGES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A SUPPLEMENTAL REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CONSUMER ALLEGED PERIOD DELAYS, CANDIDA INFECTIONS, AND SURGERY TO REMOVE EXTERNAL CYSTS ON VULVA. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939643 THINX PAD, MENSTRUAL, REUSABLE NUQ THINX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention