BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURITY OIL EMULSION DSG 3X8 PKG/3

    MDR report key: 3430376 · Received October 15, 2013

    Report

    Report Number
    1018120-2013-00007
    Event Type
    Other
    Date Received
    October 15, 2013
    Report Date
    October 3, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GEL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN EMULSION DRESSING. THE CUSTOMER REPORTS THAT THE DRESSING WAS PLACED ON A WOUND ON HER LOWER BACK, BETWEEN THE WOUND AND A WOUND VAC DRESSING. THE PATIENT STATED THEY HAD A CHRONIC STAPH INFECTION. THE PATIENT STATED THAT THE SKIN GREW AROUND THE DRESSING, THEY HAD DISCOVERED THAT THE DRESSING WAS NOT REMOVED AND HER SURGEON CUT IT OUT OF THE WOUND. THE PATIENT STATED THAT THEY ARE NOT SURE IF ALL OF THE DRESSING WAS ABLE TO BE REMOVED. THE PATIENT STATED THE DRESSING WAS IN PLACE FOR ONE MONTH. THE CUSTOMER FURTHER REPORTED SHE IS WAITING FOR HER HEALTH INSURANCE COMPANY TO APPROVE A CT SCAN THAT IS BEING ORDERED BY HER WOUND CARE PHYSICIAN. THE CUSTOMER STATED THAT LAST FRIDAY, (B)(6) 2013, HER WOUND CULTURE REPORT STILL REPORTED A STAPH INFECTION. THEY HAVE NOT YET BEEN ABLE TO DETERMINE IF THIS PRODUCT IS STILL EMBEDDED IN THE WOUND. THE WOUND IS STILL CLOSING AND THE CUSTOMER STATED THAT SHE WAS TOLD THAT IF THE OPENING OF THE WOUND CLOSES, THAT SHE WILL NEED EXPLORATORY SURGERY TO LOOK FOR MORE FOREIGN BODY. THE CUSTOMER REPORTS AS OF LAST FRIDAY (B)(6) 2013, SHE WAS PLACED ON ANOTHER COURSE OF IV ANTIBIOTICS FOR AT LEAST ANOTHER 3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528047 CURITY OIL EMULSION DSG 3X8 PKG/3 EMULSION DRESSING GEL COVIDIEN 6115 130000982762

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention