BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM S-C TIE OLIVETIP CH14

    MDR report key: 5870179 · Received August 11, 2016

    Report

    Report Number
    3005945907-2016-00005
    Event Type
    Injury
    Date Received
    August 11, 2016
    Report Date
    August 11, 2016
    Manufacturer
    COLOPLAST A/S
    Product Code
    KOD
    UDI-DI
    05708932999670
    PMA / PMN Number
    K100878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS WERE RECEIVED FOR TESTING. NO ADDITIONAL COMPLAINTS REGISTERED REGARDING THIS LOT NO. 4926535. CAPA (B)(4) WAS INITIATED ON (B)(6) 2016 TO FOLLOW THIS ISSUE, SO COMPLAINT CLOSED NOW.

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, END-USER HAD A DAMAGED PRODUCT. END-USER DOES NOT THINK THAT ANY OF THE CATHETER REMAINS IN HIM. APPEARANCE OF A CRACK IN THE CATHETER NEAR THE BEND AND A BARB LIKE PROJECTION MAKING THE WITHDRAWAL PAINFUL. THE BLEEDING HAS SUBSIDED AND HAS A DOCTOR'S APPOINTMENT NEXT MONTH. ADVISED TO SEEK MEDICAL ATTENTION IMMEDIATELY IF ANY FURTHER ISSUES ARISE AND HE HAS AGREED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520227 FREEDOM S-C TIE OLIVETIP CH14 INTERMITTENT CATHETER KOD COLOPLAST A/S 5047401400 4926535 05708932999670

    Patients

    Seq Age Sex Outcome Treatment
    1 Other