BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERY EXTERNAL MALE CATHETER

    MDR report key: 4223714 · Received November 1, 2014

    Report

    Report Number
    1063299-2014-00002
    Event Type
    Injury
    Date Received
    November 1, 2014
    Date of Event
    August 12, 2014
    Report Date
    October 30, 2014
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BIODERM DEVICE HISTORY FILE FOR LOT NUMBER Z16101 HAS BEEN REVIEWED BY REGULATORY AFFAIRS AND FOUND TO BE WITHIN SPECIFICATIONS. COMPLAINT FILES HAVE BEEN REVIEWED FOR ANY ADD'L COMPLAINTS FOR THAT LOT NUMBER AND NONE EXIST. CUSTOMER AND CAREGIVER HAVE BEEN ASKED TO SIGN A RELEASE OF MEDICAL RECORDS BUT HAVE DECLINED UNTIL THEY SEE THE ATTENDING UROLOGIST IN MID (B)(6). AS SOON AS THE CUSTOMER DETERMINES THAT HE WILL SIGN A RELEASE, WE WILL REQUEST RECORDS. THEN AS SOON AS WE RECEIVE THE RECORDS WE WILL INITIATE A REVIEW WITH OUR MEDICAL CONSULTANTS AND CLOSE THIS REPORT. IF THE REQUEST IS DENIED BY THE CUSTOMER, WE WILL CLOSE BASED ON THE CURRENT DATA. AT THIS POINT, THERE IS NO EVIDENCE TO INDICATE THAT THE MEN'S LIBERTY WAS CAUSAL TO THIS EVENT.

    Description of Event or Problem · 1

    CARE GIVER REPORTS HOSPITALIZATION FOR SEPSIS, (B)(6) 2014. DISCHARGED (B)(6) 2014. THIS REPORT WAS MADE TO BIODERM ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700303 MEN'S LIBERY EXTERNAL MALE CATHETER LIBERY EXTERNAL CATHETER NOA BIODERM, INC. 23046 Z16101

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization