BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 23209854 · Received October 3, 2025

    Report

    Report Number
    3011109575-2025-00064
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 25, 2025
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    PMA / PMN Number
    K131198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO PROCESS CONTROLS DURING MANUFACTURING AT THE PETAL FORMING STATION. AT THIS TIME, THE AFFECTED PRODUCT HAS BEEN DISCONTINUED, AND NO FURTHER MANUFACTURING WILL BE UNDERTAKEN. IF PRODUCTION IS RESUMED IN THE FUTURE, IMPROVED PROCESS CONTROLS WILL BE IMPLEMENTED AT THE PETAL FORMING STATION PRIOR TO MANUFACTURING. ADDITIONAL INFORMATION: G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: IF FOLLOW-UP, WHAT TYPE? H6: INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION. H11: MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    THE PRODUCTION IDENTIFIERS OF EXPIRATION DATE AND LOT NUMBER WERE NOT AVAILABLE FROM THE CONSUMER. THE CONSUMER DID NOT HAVE THE PACKAGE. THE INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 0

    CONSUMER REPORTED VIA EMAIL THAT WITH AN UNSPECIFIED NUMBER OF PESSARIES, THE APPLICATOR PETALS WERE BENT. THIS CAUSED PAIN WHEN INSERTING. SHE DID NOT REPORT THE NEED FOR MEDICAL ATTENTION AND SHE DID NOT REPORT ANY SERIOUS ADVERSE HEALTH EFFECTS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S USE OF THE PRODUCT AND OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433674 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V PESSARY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female