BEUDAMED
    FDA Adverse Event Summary report: N

    PROBE COVER 6X48

    MDR report key: 3233992 · Received July 16, 2013

    Report

    Report Number
    1047429-2013-00003
    Date Received
    July 16, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 15, 2013
    Manufacturer
    MICROTEK MED INC.
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 AVID MEDICAL RECEIVED A COMPLAINT FROM (B)(6) HOSPITAL ((B)(6)) STATING THAT TWO HOLES WERE FOUND ON EITHER SIDE OF PROBE COVER MICROTEK ITEM #PC1290NS AFTER USE. WE CONTACTED THE HOSPITAL ON (B)(6) 2013 TO OBTAIN FURTHER INFO AND WERE DIRECTED TO (B)(6) WHO EXPLAINED THAT THERE WAS FLUID PUT IN THE PROBE COVER BEFORE PLACING THE PROBE IN THE COVER AND IT WAS NOTICED AFTER THE PROBE HAD BEEN USED THAT THERE WAS FLUID COMING OUT OF THE PROBE COVER ON BOTH SIDES ALONG THE EDGE. (B)(6) CONFIRMED THAT THERE WAS NO PT INJURY AT THAT TIME. IT WAS FURTHER REPORTED TO US ON (B)(6) 2013 BY (B)(6) HOSPITAL ((B)(6)) THAT THE PT ON WHICH THE COMPLAINED PROBE OVER WAS USED HAD BEEN READMITTED TO HOSPITAL A WEEK AFTER THE ORIGINAL SURGERY AS A PRECAUTION BECAUSE THE PT SHOWED SLIGHT SIGNS OF INFECTION. WE CONTACTED (B)(6) ON (B)(4) 2014 AND SHE STATED THAT THE PT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329178 PROBE COVER 6X48 MED MICROTEK MED INC. PC1290N DC122157

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK