BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDICATH COMPACT SET (FOR MALES ONLY)

    MDR report key: 14469884 · Received May 23, 2022

    Report

    Report Number
    3006606901-2022-00012
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    May 2, 2022
    Report Date
    July 21, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    GBM
    PMA / PMN Number
    K121458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE USED ITEM WAS NOT REQUESTED TO BE RETURNED, AS AT NYI SITE ACCORDING TO THE INSTRUCTION, IT IS NOT NECESSARY TO TEST THOSE USED/CONTAMINATED SAMPLES (BECAUSE OF HEALTH RISK) WHICH HAVE DEFECTS. THE RELEVANT PRODUCTION DOCUMENTATION WAS CHECKED IN THE DATABASE AND NONCONFORMITY WAS NOT REVEALED THAT COULD BE RELATED TO THE DESCRIBED PRODUCT FAULT. ALSO, QUALITY ENGINEERS OF NYÍRBÁTOR HAVE ALSO CHECKED THE MANUFACTURING PROCESS RELATED TO THE GIVEN FINISHED GOOD LOT NUMBER AND NO NONCONFORMITY WAS FOUND THAT COULD CAUSE THIS CASE. NO FURTHER INFORMATION IS AVAILABLE. 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 SECOND FOLLOW-UP REPORT WILL BE SUBMITTED. SECTION H3 HAS BEEN UPDATED TO THE DEVICE NOT RETURNED TO MANUFACTURER. ANNEX B HAS BEEN CHANGED TO CODE B17 AND B14 HAS BEEN ADDED. ANNEX C HAS BEEN CHANGED TO CODE C22. ANNEX D HAS BEEN CHANGED TO CODE D15.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT DESCRIBES AN EXPERIENCED END-USER WHO CATHETERISED WITH SPEEDICATH COMPACT MALE, AND WHO DESCRIBES THAT PART OF THE CATHETER STAYED IN THE URETHRA UPON REMOVAL. THE END-USER HAD THE CATHETER PART REMOVED AT MEDICAL CONSULTATION AND HENCE, HOSPITALIZATION WAS NOT NEEDED. THE END-USER HAD NO FURTHER DAMAGE AND IS CURRENTLY DOING WELL AND IS STILL USING COLOPLAST CATHETERS. NO FURTHER INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618393 SPEEDICATH COMPACT SET (FOR MALES ONLY) SCS MALE CH 12/18 GBM COLOPLAST A/S 2842211508 7676235

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention