BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY EXTERNAL MALE CATHETER

    MDR report key: 4006371 · Received August 9, 2014

    Report

    Report Number
    1063299-2014-00001
    Event Type
    Injury
    Date Received
    August 9, 2014
    Date of Event
    July 12, 2014
    Report Date
    August 8, 2014
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS USED LIBERTY SINCE (B)(6) 2013 WITH NO REPORTS OF PREVIOUS PROBLEMS RELATED TO THE MEN'S LIBERTY. AN EXAMINATION OF THE COMPLAINT FILE INDICATES THAT THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. AT THIS TIME THERE IS NO EVIDENCE OF A CAUSAL RELATIONSHIP BETWEEN THE MEN'S LIBERTY EXTERNAL CATHETER AND THIS EVENT EXPERIENCED BY THE CUSTOMER. MEDICAL RECORDS HAVE BEEN REQUESTED FROM HEALTH CARE PROVIDERS. AS SOON AS MEDICAL RECORDS ARE REVIEWED BY THE BIODERM MEDICAL CONSULTANT, WE WILL FILE A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM CARE GIVER ON (B)(6) 2014 THAT CUSTOMER HAD BEEN DISCHARGED FROM THE HOSP THAT DAY. CARE GIVER STATED THAT ON (B)(6) 2014 HER PT (OUR CUSTOMER) HAD COMPLAINED OF BURNING ON URINATION AND CARE GIVER SCHEDULED AN APPOINTMENT WITH THE PHYSICIAN FOR (B)(6) 2014. WHILE AT THE PHYSICIAN'S OFFICE, THE PHYSICIAN WANTED A URINE SAMPLE BUT DID NOT WANT TO REMOVE THE LIBERTY CATHETER AND ASKED THE CARE GIVER TO COLLECT THE SAMPLE THE NEXT DAY. THE NEXT DAY, THE CARE GIVER WENT TO THE HOUSE TO COLLECT THE SAMPLE AND FOUND THE PT FEBRILE AND CONFUSED. SHE CALLED THE PHYSICIAN AND DESCRIBED THE SYMPTOMS AND THE PHYSICIAN ORDERED MEDICAL TRANSPORT TO THE HOSP FOR EVAL. THE CARE GIVER STATES THE EMERGENCY DEPT PHYSICIAN DIAGNOSED THE CUSTOMER WITH PNEUMONIA AND URINARY TRACT INFECTION AND ADMITTED THE CUSTOMER TO THE HOSP FOR TREATMENT ON (B)(6) 2014. CAREGIVER REPORTS A HOSP STAY UNTIL (B)(6) 2014. CUSTOMER WAS DISCHARGED TO HOME ON (B)(6) 2014. THERE WAS NOT A DISCHARGE TO A REHABILITATION FACILITY NEEDED FOR THE CUSTOMER. THE CUSTOMER HAD A PICC LINE INSERTED AT THE HOSP AND THE CAREGIVER WAS TRAINED TO ADMINISTER IV ANTIBIOTICS, 1 GRAM CEFTRIAXONE (ROCEPHIN) QD. THE CUSTOMER WILL BE FOLLOWED BY A HOME HEALTH NURSE ALSO. AT THE TIME OF OUR CONVERSATION WITH THE CARE GIVER AND THE CUSTOMER ON (B)(6) 2014 THE CUSTOMER WAS AFEBRILE AT HOME AND AMBULATORY WITH A WALKER. CARE GIVER STATES HE IS RECOVERING WELL. AT THE TIME OF OUR CONVERSATION WITH THE CAREGIVER ON (B)(6) 2014, THE PHYSICIAN HAS DISCONTINUED IV THERAPY AND PLACED THE CUSTOMER ON PO ANTIBIOTICS. CAREGIVER STATES THE CUSTOMER IS "WALKING AROUND AND DOING VERY WELL" WITH HOME HEALTH PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473583 MEN'S LIBERTY EXTERNAL MALE CATHETER LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 Z13601

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Hospitalization| O UNK AT THIS DATE (B)(6) 2014