BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA UROSTOMY W/ ACCUSEAL

    MDR report key: 3223758 · Received July 10, 2013

    Report

    Report Number
    9618003-2013-00001
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    CONVATEC
    Product Code
    EXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY SINCE (B)(4) TO ENABLE US TO EVALUATE THIS CASE BETTER, BUT NO ADDITIONAL INFORMATION WAS RECEIVED. OUR SALES REP ASKED ABOUT THE DETAILS OF THE ADVERSE EVENT TO THE RETAILER, (B)(6), BUT THE RETAILER DECLINED TO OPEN FURTHER INFORMATION. THEY WERE CONCERNED WITH THE PRIVACY OF THE PT. AS FAR AS WE KNOW, THE PT WAS ALREADY RECOVERED WHEN HE REPORTED THIS ISSUE ON (B)(6). THESE DEVICES ARE FITTED WITH NON-RETURN VALVES SPECIFICALLY TO PREVENT THE BACKFLOW OF URINE INTO THE BODY. WE DO NOT HAVE A DIAGNOSIS FROM THE HOSPITAL OR MEDICAL PERSONNEL, NEITHER DO WE HAVE ANY RECORD OF THE TREATMENT GIVEN, IF ANY. THE USE OF THE DEVICE CANNOT; HOWEVER, BE RULED OUT AS BEING CAUSALLY RELATED TO THE EVENT. TO ERR ON THE SIDE OF CAUTION, WE ARE DEEMING THIS A SERIOUS INJURY AS THE COMPLAINT NARRATIVE MENTIONED THAT THE PT SUFFERED A FEVERISH ILLNESS AS A RESULT OF THE EVENT. URINE WONT DRAIN COMPLAINT ISSUE WAS INVESTIGATED IN DETAIL BY CONVATEC QUALITY ENGINEERING. NON-CONFORMANCE RECORD AND CORRECTIVE ACTION RECORDS WERE GENERATED TO ADDRESS THIS ISSUE AND DOCUMENT THE RESULTS OBTAINED FROM THE INVESTIGATION. THE DETAILS OF THE INVESTIGATION ARE DOCUMENTED IN COMPLAINT INVESTIGATION REPORT LOCATED IN OUT DOCUMENT CONTROL SYSTEM. CONVATEC WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINT. (B)(4). NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: URINE DIDN'T DRAIN FROM POUCH TO DRAINAGE BAG AND FLOWED BACK TO THE STOMA WHILE SLEEPING IN THE NIGHT. BECAUSE OF THIS REFLUX, A FEVER WAS DEVELOPED AND USER FELT ILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316208 SUR-FIT NATURA UROSTOMY W/ ACCUSEAL BAG, URINARY EXH CONVATEC NA 2L02357

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other