BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M TEGADERM ALGINATE AG SILVER DRESSING

    MDR report key: 5738466 · Received June 21, 2016

    Report

    Report Number
    2110898-2016-00068
    Event Type
    Injury
    Date Received
    June 21, 2016
    Date of Event
    June 8, 2016
    Report Date
    June 9, 2016
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRO
    PMA / PMN Number
    K090453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER - CONFIDENTIAL: ADVANCED MEDICAL SOLUTIONS LTD (B)(4). THIS IS A PRIVATE LABEL PRODUCT. ADVANCED MEDICAL SOLUTIONS OWNS THE 510K ON THIS PRODUCT. THE 510K NUMBER K090453. AMS' DEVICE LISTING NUMBER FOR THIS PRODUCT IS D073047.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A COMPLEX MEDICAL PATIENT WITH NECROTIZING FASCIITIS OF A LEFT GROIN WOUND WAS ADMITTED TO THEIR EXTENDED CARE FACILITY. OVER THE NEXT 22 DAYS, THE PATIENT RECEIVED WOUND CARE IN THEIR FACILITY AND REQUIRED RE-HOSPITALIZATION TWICE FOR SEPSIS. FOLLOWING THE SECOND HOSPITALIZATION, THE PATIENT WAS RE-ADMITTED TO THEIR FACILITY AGAIN IN LATE (B)(6) WITH AN (B)(6) OF THE LEFT GROIN WOUND. NURSE REPORTED MD PLACED A NEW ORDER FOR ALGINATE DRESSING TO BE PACKED INTO A SMALL OPENING OF A BLIND TUNNELED AREA OF THE WOUND. THE PATIENT HAD AT LEAST TWO DRESSING CHANGES WITH THE TEGADERM ALGINATE (B)(4), 90307 AND APPROXIMATELY 13 DAYS LATER THE WOUND WAS RED, SWOLLEN AND THE ANTERIOR ASPECT HAD SOME BLOODY PURULENT DRAINAGE. A CT SCAN WAS DONE AND PATIENT WAS SENT TO THE WOUND CLINIC. THE MD OPENED A SMALL PORTION OF THE WOUND AND PULLED OUT A LONG ROPE OF INTACT PRODUCT. THE MD ALLEGED THE INFECTION WAS DUE TO RETAINED PRODUCT. NURSE STATED IT WAS UNKNOWN IF THE RETAINED PRODUCT WAS TEGADERM ALGINATE (B)(4), 90307. NURSE STATED THE RETAINED MATERIAL MAY HAVE BEEN PRODUCT THAT WAS USED PRIOR TO STARTING TEGADERM ALGINATE (B)(4), 90307. THE PATIENT RECEIVED ANTIBIOTICS FOR TREATMENT AND WAS DISCHARGED TO HOME SIX DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393014 3M TEGADERM ALGINATE AG SILVER DRESSING TEGADERM ALGINATE AG DRESSING FRO 3M HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R