BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDICATH COMPACT SET MALE CH 12/18

    MDR report key: 3230269 · Received July 16, 2013

    Report

    Report Number
    9610694-2013-00005
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 17, 2013
    Manufacturer
    COLOPLAST A/S
    Product Code
    GBM
    PMA / PMN Number
    K121458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED, A USER SELF CATHETERIZED ON (B)(6). HE FELT A LIGHT RESISTANCE BUT SUCCEEDED IN SELF-CATHETERIZING. HE NOTICED SOME TRACE AMOUNT OF BLOOD ON THE CATHETER WHEN WITHDRAWING IT. ON (B)(6), WHEN HE GOT UP HE NOTICED THAT THE BAG ATTACHED TO HIS URISHEATH WAS FULL OF BLOOD. HE WAS HOSPITALIZED FOR URETERORRHAGIA AND HAD AN INDWELLING CATHETER FOR 15 DAYS. HE LEFT THE HOSPITAL ON (B)(6). THE INDIVIDUAL SAW HIS UROLOGIST AND HAD AN ENDOSCOPY ON (B)(6). THE EXAM DID NOT REVEAL ANY PROBLEM AND EVERYTHING IS NOW OK FOR HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329853 SPEEDICATH COMPACT SET MALE CH 12/18 INTERMITTENT URINARY CATHETER GBM COLOPLAST A/S 2842211001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other