BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDICATH STANDARD (MALE)

    MDR report key: 10662961 · Received October 12, 2020

    Report

    Report Number
    3006606901-2020-00012
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    September 12, 2020
    Report Date
    October 12, 2020
    Manufacturer
    COLOPLAST HUNGARY - NYI
    Product Code
    GBM
    PMA / PMN Number
    K180258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THIS CASE INVOLVES AND MALE USER THAT IS IN A WHEELCHAIR AND PARTIALLY PARALYZED WHO WAS INADVERTENTLY GIVEN SPEEDICATH TIEMANN CATHETERS INSTEAD OF SPEEDICATH STANDARD CATHETERS. HE NOTICED THAT THE CATHETERS LOOKED DIFFERENT; HOWEVER, USED THEM AS HE HAD NO OTHERS TO USE. FORCE WAS APPLIED WHEN ATTEMPTING TO USE THE FIRST CATHETER; HOWEVER, INSERTION WAS UNSUCCESSFUL. A SECOND ATTEMPT WAS MADE WHICH RESULTED IN BLEEDING. ON (B)(6) 2020, HE VISITED AN EMERGENCY CLINIC FOR ASSISTANCE WITH CATHETERIZATION; HOWEVER, IT WAS UNSUCCESSFUL AND HE WAS SENT HOME WITH A FULL BLADDER. HE THEN BEGAN TO FEEL WORSE NOTICING BLOOD AND URINE ON HIS BED. ON (B)(6) 2020, HE RETURNED TO THE EMERGENCY ROOM WHERE HE COLLAPSED, WAS INTUBATED AND WAS TRANSFERRED TO THE HOSPITAL WHERE HE LAPSED INTO A COMA WHICH LASTED FOR 4 DAYS. SEPSIS WAS DIAGNOSED; HOWEVER, IT IS UNKNOWN WHAT TREATMENT, IF ANY, WAS PERFORMED. HE WAS TRANSFERRED FROM THE UROLOGICAL UNIT TO THE INTENSIVE CARE UNIT WHERE HE REMAINED UNTIL (B)(6) 2020. HE IS CURRENTLY UNDERGOING MEDICAL REHABILITATION WITH A PLANNED DISCHARGE DATE OF (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126844 SPEEDICATH STANDARD (MALE) CATHETER, URETHRAL GBM COLOPLAST HUNGARY - NYI 2749201028

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization