BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PENILE PROSTHESIS

    MDR report key: 9365369 · Received November 22, 2019

    Report

    Report Number
    2125050-2019-01041
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    October 17, 2019
    Report Date
    November 18, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    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 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 · 1

    ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION WAS REPORTED. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158086 UNKNOWN PENILE PROSTHESIS PENILE PROSTHESIS FAE COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other