BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDICATH COMPACT MALE

    MDR report key: 12153808 · Received July 12, 2021

    Report

    Report Number
    3006606901-2021-00019
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    June 12, 2021
    Report Date
    December 22, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    GBM
    PMA / PMN Number
    K143182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CODE E050602 HAS BEEN ADDED TO ANNEX E AND CODE F1203 HAS BEEN ADDED TO ANNEX F.

    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. N/A.

    Description of Event or Problem · 1

    A (B)(6) MALE (END-USER) HAD REQUESTED SAMPLES OF COMPACT CATHETERS AND WERE SEND SPEEDICATH COMPACT MALE. THE END-USER HAS BEEN CATHETERIZING SINCE 2015, THE USE BEING INDICATED BY ENLARGED PROSTATE. AFTER TRYING SPEEDICATH COMPACT MALE, HE STARTED TO BLEED. THE MEDICAL DOCTOR SAID THE CATHETER HAD CAUSED A SCRAPE BELOW THE PROSTATE. THE END-USER HAD LOST BLOOD IN A QUANTITY THAT NECESSITATED A BLOOD TRANSFUSION, AND HE WAS ADMITTED TO THE HOSPITAL THE (B)(6) AND DISCHARGED THE (B)(6) 2021. HE HAS RECOVERED AND IS STILL CATHETERIZING. THE END-USER EXPERIENCED NO PROBLEMS WITH THE SPEEDICATH FLEX CATHETER WHICH HE ALSO RECEIVED SAMPLES OF. IT IS STATED THAT THE END-USER WAS USING A FLEXIBLE CATHETER BEFORE THE INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049418 SPEEDICATH COMPACT MALE SPEEDICATH COMPACT M CH 12-18 GBM COLOPLAST A/S 2869201404

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Life Threatening| H| R