BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAF-GEL HYDRATING DERMAL WOUND DRSG GEL

    MDR report key: 3426567 · Received October 17, 2013

    Report

    Report Number
    2243969-2013-00145
    Event Type
    Injury
    Date Received
    October 17, 2013
    Date of Event
    September 18, 2013
    Report Date
    September 18, 2013
    Manufacturer
    ACCUPAC, INC.
    Product Code
    KMF
    PMA / PMN Number
    K942270
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. SHE USES SALINE TO CLEAN THE WOUND. SAF-GEL WAS INDICATED BY VASCULAR PHYSICIAN. THE PT DOESN'T USE ANY DRUGS. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN SAF-GEL HYDRATING DERMAL WOUND DRESSING GEL AND THIS EVENT IS DEEMED POSSIBLE BECAUSE THE PRODUCT IN USE IS TEMPORALLY ASSOCIATED WITH THE SKIN WHERE THE PROBLEM OCCURRED. NO ADDITIONAL EVENT/PT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. REPORTED TO THE FDA ON (B)(4) 2013. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    END USER REPORTS FELT PAIN FOR 1 HOUR UPON APPLYING SAF-GEL. TWO DAYS AFTER APPLICATION, APPEARED BLACK DOTS IN THE CENTER OF THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532917 SAF-GEL HYDRATING DERMAL WOUND DRSG GEL HYDROGEL WOUND AND BURN DRESSING KMF ACCUPAC, INC. 145730 3402A1

    Patients

    Seq Age Sex Outcome Treatment
    1