BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE PRODUCTS

    MDR report key: 20571282 · Received October 30, 2024

    Report

    Report Number
    1049092-2024-00130
    Event Type
    Injury
    Date Received
    October 30, 2024
    Report Date
    October 18, 2024
    Manufacturer
    CONVATEC
    Product Code
    EZD
    UDI-DI
    00815947020345
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS 1. RAISED BUMPS ON HNC CATHETER: ANALYSIS & INSPECTION: 13 RETAINED SAMPLES WERE TESTED; NO SIMILAR DEFECTS FOUND. POSSIBLE CAUSES: SPECULATED TO BE EXTRUSION DEFECTS OR BENDING DURING TRANSPORTATION. MANUFACTURING PROCESS REVIEW: EQUIPMENT WAS FUNCTIONING CORRECTLY, MATERIAL WAS WITHIN SPECIFICATIONS, AND QUALITY CHECKS WERE CONDUCTED REGULARLY. CONCLUSION: NO DEFINITIVE ROOT CAUSE DETERMINED DUE TO LACK OF PHYSICAL SAMPLES OR IMAGES FROM THE USER. 2. BURNING SENSATION FROM ULTRA CATHETER: POSSIBLE CAUSES: INADEQUATE GEL APPLICATION, LEADING TO INSUFFICIENT LUBRICATION. PRE-EXISTING URETHRAL MUCOSAL DAMAGE, WHICH COULD BE EXACERBATED. PRODUCTION REVIEW: GEL FILLING MACHINE WAS WITHIN SPECIFICATION, AND NO ANOMALIES WERE DETECTED. CONCLUSION: SINCE BATCH DETAILS WERE UNAVAILABLE, THE INVESTIGATION COULD NOT DETERMINE THE ROOT CAUSE. THIS INVESTIGATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, SOP-000741. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 3005471919.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092, MANUFACTURING SITE: 3005471919.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    END USER REPORTED HE HAD 2 RECENT UTIS. HE HAD HIS FIRST UTI IN EARLY SEPTEMBER WHICH HE SAID HE HAD FREQUENCY, URGENCY, BLEEDING NOTED IN HIS URINE AND HIS PROSTATE WAS SWOLLEN. HE SAW HIS MD AND HAD URINE TESTING. THE BACTERIA AEROCOCCUS WAS FOUND IN HIS URINE AND HE WAS PRESCRIBED NITROFURANTOIN WHICH RESOLVED HIS SYMPTOMS. HIS MD SAID THIS BACTERIA IS RARE BUT OFTEN FOUND IN HOSPITALS BUT HIS ONLY PRIOR INTERVENTION WAS IN JUNE WITH THE UROLIFT BUT IT WAS POSSIBILITY FROM THAT. THEN 2.5 - 3 WEEKS LATER HE HAD URGENCY FREQUENCY AGAIN AND THAT TIME WAS GETTING HIS URINE CHECKED FOR A PHYSICAL AND THE BACTERIA THAT GREW OUT WAS ENTEROCOCCUS. IT WAS DEEMED HIS SECOND UTI; HE WAS PRESCRIBED AMOXICILLIN AND FINISHED THAT COURSE LAST SAT AND IS FEELING BETTER. HIS MD MENTIONED THAT SOMETIMES ENTEROCOCCUS CAN GROW WHEN AN AEROCOCCUS INFECTION WAS RECENTLY TREATED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034642 CURE PRODUCTS CATHETER, STRAIGHT EZD CONVATEC HM14C 23B18201 00815947020345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention