BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRE SINGLE ELECTRODE PROBE

    MDR report key: 1657896 · Received April 7, 2010

    Report

    Report Number
    1319211-2010-00014
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 31, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OHJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE LOT NUMBER WAS NOT PROVIDED. A SHIP HISTORY SHOWED THAT THE FOLLOWING LOTS HAD BEEN SHIPPED IN THE LAST 6 MONTHS: 081106 AND 080911. THE COMPLAINT INFO WAS FORWARDED TO (B)(4). (B)(4) REVIEWED THE POSSIBLE LOT HISTORY RECORDS AND FOUND NO VARIANCES RELATED TO THIS EVENT WERE OBSERVED. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVAL. CONCLUSION: THIS TYPE OF COMPLAINT IS STILL CURRENTLY UNDER INVESTIGATION. F/U REPORT TO FOLLOW. FREQUENCY HAS INCREASED, BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    PT WAS TREATED BY DR (B)(6) MEDICAL CENTER, (B)(6) 2010. IMMEDIATELY PRIOR TO IRREVERSIBLE ELECTROPORATION TREATMENT, PT HAD BEEN VOIDING FREELY WITHOUT ASSISTANCE. PT DOES HAVE A HISTORY OF POST-SURGICAL URINARY RETENTION AFTER ABDOMINAL PERITONEAL RESECTION. HE REPORTED TO DR (B)(6) NURSE THAT HE HAD TO DO SELF-STRAIGHT-CATHETERIZATION FOR A PERIOD OF ABOUT 2 MONTHS AFTER APR. HE EVENTUALLY REGAINED VOIDING INDEPENDENCE. DURING THE IRE PROCEDURE, PT DID NOT HAVE AN INDWELLING FOLEY CATHETER. AFTER PROCEDURE, HE DEVELOPED URINARY RETENTION. SEVENTY TWO HOURS POST IRE, PT IS PERFORMING INTERMITTENT STRAIGHT CATHETERIZATION TO DRAIN BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRE SINGLE ELECTRODE PROBE IRE SINGLE ELECTRODE PROBE OHJ ANGIODYNAMICS NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention