BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN VIEW STANDARD MALE EXTERNAL CATHETER

    MDR report key: 3162092 · Received May 30, 2013

    Report

    Report Number
    2130787-2013-00001
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ROCHESTER MEDICAL CORP.
    Product Code
    EXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013, ROCHESTER MEDICAL CORPORATION WAS NOTIFIED THAT AN END USER OF A MALE EXTERNAL CATHETER HAD DIFFICULTY IN REMOVING THE CATHETER. THE END USER REPORTED THAT THE ADHESIVE APPEARED TO BE TOO STRONG AND INJURED HIS PENIS. THE END USER REPORTED THAT HE CONSULTED A DERMATOLOGIST WHO PRESCRIBED MUPIROCIN OINTMENT AS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238488 IN VIEW STANDARD MALE EXTERNAL CATHETER MALE EXTERNAL CATHETER EXJ ROCHESTER MEDICAL CORP. 97536 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other