BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHESTER INTERMITTENT MAGIC3 HYDRO WITH SURE-GRIP 14 MALE 30BX

    MDR report key: 6094388 · Received November 10, 2016

    Report

    Report Number
    1018233-2016-01601
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    August 19, 2017
    Manufacturer
    DAVOL SURGICAL INNOVATIONS -9616067
    Product Code
    KOD
    PMA / PMN Number
    K000723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS UNCONFIRMED SINCE ALL THE SAMPLES (3) WERE WITHIN SPECIFICATION, FOR 14 FRENCH SIZE THE IS 0.183 WITH A TOLERANCE OF ±0.013, THE RESULTS WERE RECORDED IN (B)(4) - IN-PROCESS INSPECTION RECORD FOR ISC, REV 2 (SEE FM IN EVALUATION ATTACHMENT SECTION). THE SAMPLES HAS THE FOLLOWING RESULTS: (B)(6). THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: ¿THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PATIENTS REQUIRING CATHETERIZATION FOR MANAGEMENT OF INCONTINENCE, VOIDING DYSFUNCTION, AND SURGICAL PROCEDURES. PLEASE CONTACT YOUR PHYSICIAN TO DETERMINE WHICH PRODUCT OPTIONS ARE BEST FOR YOU, PAYING CLOSE ATTENTION TO PRODUCT WARNINGS/ PRECAUTIONS AND ADVERSE REACTIONS.(B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SEEMED TO HAVE A SMALLER DIAMETER THAN USUAL. THE PATIENT WAS ALLEGEDLY UNABLE TO INSERT THE CATHETER. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SEEMED TO HAVE A SMALLER DIAMETER THAN USUAL. THE PATIENT WAS ALLEGEDLY UNABLE TO INSERT THE CATHETER. NO PATIENT INJURY WAS REPORTED, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SEEMED TO HAVE A SMALLER DIAMETER THAN USUAL. THE PATIENT WAS ALLEGEDLY UNABLE TO INSERT THE CATHETER. NO PATIENT INJURY WAS REPORTED, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SEEMED TO HAVE A SMALLER DIAMETER THAN USUAL. THE PATIENT WAS ALLEGEDLY UNABLE TO INSERT THE CATHETER. NO PATIENT INJURY WAS REPORTED, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SEEMED TO HAVE A SMALLER DIAMETER THAN USUAL. THE PATIENT WAS ALLEGEDLY UNABLE TO INSERT THE CATHETER. NO PATIENT INJURY WAS REPORTED, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SEEMED TO HAVE A SMALLER DIAMETER THAN USUAL. THE PATIENT WAS ALLEGEDLY UNABLE TO INSERT THE CATHETER. NO PATIENT INJURY WAS REPORTED, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SEEMED TO HAVE A SMALLER DIAMETER THAN USUAL. THE PATIENT WAS ALLEGEDLY UNABLE TO INSERT THE CATHETER. NO PATIENT INJURY WAS REPORTED, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744187 ROCHESTER INTERMITTENT MAGIC3 HYDRO WITH SURE-GRIP 14 MALE 30BX MAGIC 3 CATHETER KOD DAVOL SURGICAL INNOVATIONS -9616067 NGAU3424

    Patients

    Seq Age Sex Outcome Treatment
    1