BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTOMY ROD

    MDR report key: 15632801 · Received October 19, 2022

    Report

    Report Number
    3006606901-2022-00022
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    September 1, 2021
    Report Date
    October 19, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZP
    PMA / PMN Number
    K052229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, COLOPLAST HAS INITIATED A PMCF STUDY AS AN ONLINE SURVEY COORDINATED BY AN EXTERNAL PARTNER. WHEN COLOPLAST RECEIVED THE FEED-BACK FROM THE SURVEY AN INCIDENT WAS IDENTIFIED, WHERE IT WAS STATED THAT STOMA NECROSIS OCCURRED REPORTEDLY RELATED TO THE USE OF OSTOMY ROD. NO FURTHER INFORMATION AVAILABLE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2939006 OSTOMY ROD OSTOMY ROD STERILE EZP COLOPLAST A/S 1281401004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening