BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PESSARY FITTING SET OF 6 SIZES

    MDR report key: 3802651 · Received February 25, 2014

    Report

    Report Number
    2523190-2014-00011
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 4, 2014
    Manufacturer
    INTEGRA YORK, PA INC
    Product Code
    HHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE DOCTOR INSERTED TWO PESSARIES (FROM THE FITTING SET) AND THEY WERE NOT IN FOR MORE THAN 30 SECONDS. EVERYTHING SEEMED FINE AND THEN 4-5 HOURS LATER THAT EVENING THE PT STARTED TO HAVE SOME VAGINAL BURNING AND TROUBLE HAVING A BOWEL MOVEMENT. PT REPORTS SHE HAS NEVER HAD A PROBLEM WITH LATEX GLOVES SO SHE THOUGHT MAYBE THIS WAS DUE TO A SILICON ALLERGY. ON (B)(6) 2014, PT REPORTS THAT FOR SIZING PURPOSES A #4 PESSARY WAS INSERTED/REMOVED AND A #5 PESSARY WAS INSERTED/REMOVED. PT IS ALLERGIC TO LUBRICANTS SO DEVICES WERE INSERTED USING WATER. DOCTOR DOES NOT BELIEVE SHE WAS REACTING TO THE DEVICE BUT COULD NOT RULE IT OUT. ON (B)(6) 2014, DOCTOR REPORTS EVENT OCCURRED (B)(6) 2014. PT WAS REEXAMINED (B)(6) 2014 AND STILL HAD SOME DISCOMFORT. DOCTOR FOUND NO INFLAMMATION OR DRAINAGE IN VAGINAL CANAL. PT WAS REFERRED TO AN ALLERGIST. PT HAS NOT BEEN HEARD FROM SINCE (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116234 PESSARY FITTING SET OF 6 SIZES M7-OB-GYN HHW INTEGRA YORK, PA INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR