BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 23464875 · Received November 4, 2025

    Report

    Report Number
    3011109575-2025-00082
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 25, 2025
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    UDI-DI
    00036000496185
    PMA / PMN Number
    K131198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED FROM CONSUMER WERE CONSISTENT WITH THE REPORTED COMPLAINT. 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 INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 0

    CONSUMER REPORTED THAT THE APPLICATOR PETALS OF AN UNSPECIFIED NUMBER OF PESSARIES WERE PARTIALLY OPEN AND DURING INSERTION SHE WAS PINCHED AND NOTICED BLOOD AND A CUT. SHE HAS IMPROVED. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY SERIOUS ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2729279 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V PESSARY NN520571A 00036000496185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female