BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAF-GEL HYDRATING DERMAL WOUND DRSG GEL

    MDR report key: 3367783 · Received September 17, 2013

    Report

    Report Number
    2243969-2013-00092
    Event Type
    Injury
    Date Received
    September 17, 2013
    Date of Event
    August 19, 2013
    Report Date
    August 19, 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. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN SAF-GEL HYDRATING DERMAL WOUND DRSG GEL AND THIS EVENT IS DEEMED POSSIBLE BECAUSE THE PRODUCT IN USE IS TEMPORARILY ASSOCIATED WITH THE SKIN WHERE THE PROBLEM OCCURRED. ACCORDING TO THE REPORTER, THE PT WAS INSTRUCTED TO CONSULT THEIR PHYSICIAN. 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). NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    THE PT PERFORMS THE CHARGE OF THE DRESSING EVERY 2 DAYS, CLEANS WITH SALINE, AND APPLES SAF- GEL ON THE WOUND AND AQUACEL AG AROUND THE WOUND. THE PT FELT PAIN FOR 10 MINS UPON APPLYING SAF-GEL. THE ISSUE OCCURRED IN THE LEFT FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466972 SAF-GEL HYDRATING DERMAL WOUND DRSG GEL HYDROGEL WOUND AND BURN DRESSING KMF ACCUPAC, INC. 145730 1932A2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention