BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAF-GEL - WOUND DRESSING W/ ALGINATE

    MDR report key: 3796636 · Received May 2, 2014

    Report

    Report Number
    2243969-2014-00210
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 8, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    NAE
    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 TO BE A SERIOUS INJURY BASED ON THE PT REQUIRING PRESCRIPTIVE MEDICATION AS ORDERED BY PHYSICIAN. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014. (B)(4). CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT FELT PAIN, AT ANKLE, FOR 2 HOURS UPON APPLYING SAF-GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263755 SAF-GEL - WOUND DRESSING W/ ALGINATE HYDROGEL WOUND AND BURN DRESSING NAE CONVATEC INC. 145730 3402A2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention