BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC SENSE

    MDR report key: 17478853 · Received August 8, 2023

    Report

    Report Number
    3009632672-2023-00002
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    July 23, 2023
    Report Date
    August 8, 2023
    Manufacturer
    WELLSPECT AB
    Product Code
    EZD
    UDI-DI
    07392532086489
    PMA / PMN Number
    K123751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, WELLSPECT HEALTHCARE 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 OF CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2023 A FEMALE PATIENT WITH SJOGREN'S SYNDROME (AUTOIMMUNE DISORDER), GOT AN INTERMITTENT NELATON STRAIGHT TIP CATHETER (LOFRIC SENSE FR14) STUCK IN HER URETHRA DURING WITHDRAWAL. SHE HAD THEN TO GO TO EMERGENCY CARE FOR REMOVAL. THE CATHETER WAS REMOVED IN AN ER AND A PIECE OF MUCOSAL TISSUE WAS STUCK IN AN EYELET UPON REMOVAL. THE FEMALE PATIENT HAD BLEEDING AND A HEMATOMA DUE TO THE INJURY. THE PATIENT CAREGIVER (MOTHER) NOTED THE LOFRIC SENSE SOLUTION FELT THICK AND STICKY. THE ER DOCTOR BELIEVES DIAGNOSIS OF SJOGREN'S MAY BE AN INFLUENTIAL FACTOR AS PATIENTS EXPERIENCE DRYNESS IN MUCOSAL TISSUES. WITHIN THE WEEK PRIOR TO THEIR NEXT ER VISIT, PATIENT UROLOGIST PRESCRIBED MACROBID FOR A POSSIBLE UTI. THE ER PROVIDER PRESCRIBED AN ADDITIONAL 10 DAYS OF ANTIBIOTICS AFTER REMOVING THE LOFRIC SENSE CATHETER. THE ER ADVISED TO USE ADDITIONAL GEL LUBRICANT WITH LOFRIC SENSE GOING FORWARD. THE PATIENT CAREGIVER USED THIS TECHNIQUE FOR THE WEEK FOLLOWING THEIR ER VISIT, DIDN'T HAVE ANY ISSUES WITH LOFRIC SENSE, AND THEN RECEIVED ANOTHER CATHETER SAMPLES (CURE CATHETERS (INADVERTENTLY)), BUT THEY WORKED WELL FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260670 LOFRIC SENSE LOFRIC SENSE NELATON 15CM FR14 EZD WELLSPECT AB 4161405 639815 07392532086489

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Hospitalization