BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STATSEAL DISC

    MDR report key: 10408905 · Received August 14, 2020

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    Report

    Report Number
    1066421-2020-00003
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 23, 2020
    Report Date
    August 13, 2020
    Manufacturer
    BIOLIFE, LLC
    Product Code
    FRO
    PMA / PMN Number
    K130324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION WAS PERFORMED BY BIOLIFE'S CHIEF MEDICAL ADVISOR.

    Description of Event or Problem · 1

    PRESSURE INJURY ON A PATIENT: FEMALE PATIENT 27 WEEK IUGR. (B)(6). 1.4 FRENCH PICC PLACE IN THE LEFT SAPHENOUS VEIN ON (B)(6) 2020. STATSEAL OVER INSERTION SITE DRESSING CHANGE ON (B)(6) 2020 AFTER CONCERNS OF PUFFINESS / EDEMA OF THE LOWER EXTREMITIES. PRESSURE INJURY FOUND AND STAGE (STAGE 3). PATIENT HAD BEEN ON DOPAMINE, TPN AND IL. H/O FLUID AND ELECTROLYTE BOLUSES. SURGERY CONSUL FOR ABDOMINAL DISTENSION ON (B)(6) 2020. INITIATED KERACELE AG SILVER DRESSING OVER THE WOUND AND COVERED WITH MEPILEX BORDER DRESSING. AS (B)(6) 2020, WOUND IS HEALING WELL AND DRESSING ARE CHANGE TWICE A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874817 STATSEAL DISC STATSEAL DISC FRO BIOLIFE, LLC DT623

    Patients

    Seq Age Sex Outcome Treatment
    1 27 WK Other