BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT-FLEX

    MDR report key: 1504985 · Received September 23, 2009

    Report

    Report Number
    1216677-2009-00027
    Event Type
    Malfunction
    Date Received
    September 23, 2009
    Date of Event
    August 27, 2009
    Report Date
    September 22, 2009
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OF THREE DILATORS COMPRISING THE SET WAS RETURNED. THE TIP WAS BROKE OFF. THE DILATOR HAD AN ORANGE RESIDUE AND A YELLOW STAIN ON THE TIP. THE USER FACILITY INDICATED USING DAWN DISH SOAP TO CLEAN THE DILATOR. THE DILATOR CAME IN CONTACT WITH BETADINE (IODINE). THE ORANGE RESIDUE MIGHT BE CONSIDERED AN INDICATION THE DILATOR WAS NOT CLEANED PROPERLY, I.E. A SOFT BRISTLE BRUSH WAS NOT USED TO REMOVE DIFFICULT MATTER. THE RESIDUAL BETADINE MAY HAVE INTERACTED WITH THE TEFLON MATERIAL OF THE DILATOR CAUSING BRITTLENESS. A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY SIMILARLY REPORTED COMPLAINTS. (B)(4).

    Description of Event or Problem · 1

    DURING A CERVICAL DILATATION, THE TIP OF THE DILATOR BROKE OFF IN THE PATIENT. THE BROKEN TIP WAS REMOVED FROM THE PATIENT MANUALLY (FINGERS OR FORCEPS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORT-FLEX DILATOR SET HDQ COOPERSURGICAL, INC. 64-376

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention