BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEPILEX AG

    MDR report key: 1530899 · Received November 4, 2009

    Report

    Report Number
    3004763499-2009-00012
    Event Type
    Other
    Date Received
    November 4, 2009
    Date of Event
    October 8, 2009
    Report Date
    November 4, 2009
    Manufacturer
    MOLNLYCKE HEALTH CARE
    Product Code
    FRO
    PMA / PMN Number
    K061554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE CONDUCTED AS NO LOT NUMBER OR SAMPLE WAS PROVIDED. AFTER FURTHER DISCUSSION WITH THE SURGEON, IT WAS DETERMINED THAT THE DEVICE CONTAINS SILVER SULFATE WHICH WAS COMMUNICATED TO DR. (B)(6) AND HE STATED THAT THE PT'S REACTION WAS MORE CONSISTENT WITH SILVER SULFADIAZINE. (B)(4) HAS NO EVIDENCE THAT THE (B)(4) WAS DIRECTLY RELATED TO THE PT'S CONDITION.

    Description of Event or Problem · 1

    THE DOCTOR CALLED AND STATED THAT THEY HAD GIVEN A PT A LARGE AMOUNT OF MEPILEX AG AND SUDDENLY SHE IS HAVING LEUKOPENIA. THE PT WAS ADMITTED FOR SJS ON OCT 3, THE PT'S WHITE BLOOD COUNT WAS 5.9 AND ON OCT 8, IT HAD DROPPED TO 0.6. ONCE THE DIAGNOSIS WAS MADE, THE DRESSING WAS COMPLETELY REMOVED AND HAS NOT BEEN USED AGAIN. DOCTOR REPORTED, PT IS DOING MUCH BETTER. THE PT HAS AN ALLERGY TO SULFA. THE DOCTOR WANTED TO KNOW THE MAKE-UP OF OUR MEPILEX AG CAUSE HE FELT THE REACTION WAS CONSISTENT WITH SILVER SULFADIAZINE. WE DID INFORM THE DOCTOR THAT SILVER SULFADIAZINE IS NOT PART OF THE MAKE-UP OF MEPILEX AG. THE INGREDIENTS THAT MAKE-UP MEPILEX AG ARE POLYURETHANE FOAM, POLYETHYLENE RELEASE FILM, SILICONE GEL, SILVER SULFATE (3.5% BY WT), AND ACTIVATED CHARCOAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEPILEX AG SILVER DRESSING FRO MOLNLYCKE HEALTH CARE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other