BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOUSE-PAPARELLA CUR, DBL-ENDED

    MDR report key: 582572 · Received March 18, 2005

    Report

    Report Number
    1423507-2005-00041
    Event Type
    Other
    Date Received
    March 18, 2005
    Report Date
    March 18, 2005
    Manufacturer
    CARDINAL HEALTH
    Product Code
    JYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE DOING SURGERY, THE LIP BROKE OFF IN THE PATIENT'S EAR. THE PHYSICIAN DID RETRIEVE THE PART. ADDITIONALLY, ACCOUNT STATED THAT THE PHYSICIAN WAS USING THE HOUSE-PAPARELLA CURETTES TO CURETTE THE PATIENT'S EAR WHEN THE END BROKE OFF. HE HAD TO RETRIEVE THE BROKEN PIECE WITH FORCEPS. THE PHYSICIAN LUMED THE CURETTE AROUND AND CONTINUED TO CURETTE THE PATIENT'S EAR WITH THE OPPOSITE END OF THE CURETTE, BUT THAT END BROKE OFF AS WELL. THE PHYSICIAN RETRIEVED THE BROKEN PIECE WITH FORCEPS AND COMPLETED THE CASE WITH ANOTHER CURETTE WITHOUT INCIDENT. THE ACCOUNT FURTHER STATED THAT THE CURETTE WILL BE RETURNED TO CARDINAL FOR EVALUATION AND THE REQUESTED PATIENT'S INFORMATION WILL BE PLACED IN THE BOX WITH THE CURETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOUSE-PAPARELLA CUR, DBL-ENDED CURETTE JYG CARDINAL HEALTH AU13720 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other