BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAF-GEL - WOUND DRESSING W/ ALGINATE

    MDR report key: 3381076 · Received September 30, 2013

    Report

    Report Number
    2243969-2013-00104
    Event Type
    Injury
    Date Received
    September 30, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 30, 2013
    Manufacturer
    ACCUPAC, INC
    Product Code
    NAE
    PMA / PMN Number
    K942270
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. THE PT WAS REFERRED BACK TO THE DOCTOR ON (B)(6) 2013. QUALITY RECORDS WERE REVIEWED BY THE THIRD PARTY MANUFACTURER AND NO NON-CONFORMANCES WERE IDENTIFIED. A BATCH RECORD REVIEW FOUND ALL ITEMS CORRECT AND NO IRREGULARITIES IN PRODUCTION. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE SAF-GEL WOUND DRESSING W/ ALGINATE AND THIS EVENT IS DEEMED PROBABLE BECAUSE PRODUCT USE IS TEMPORARILY ASSOCIATED WITH THE SKIN WHERE THE PROBLEM OCCURRED. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. (B)(4). THIRD PARTY MFR: (B)(4).

    Description of Event or Problem · 1

    THE PT WAS SEEN AT (B)(6) MEDICAL CARE ON (B)(6) 2013, FOR AN ULCER ON THEIR LEFT LOWER LEG (DIAMETER 6X6 CM AND 0.5 CM DEEP). THE WOUND WAS REPORTEDLY 90% DRY FIBRIN TISSUE AND 10% GRANULATION TISSUE. THE SURROUNDING SKIN HAD SIGNS OF ERYTHEMA, SCALING, AND HEAT EXTENDING TO THE LOWER PORTION OF THE LIMB. ON THE INSIDE PORTION OF THE RIGHT LOWER LEG IT WAS REPORTED ALL OF THE SKIN HAD EDEMA, ERYTHEMA, REDNESS, FLAKING, AND SLOUGH. A PEDAL PULSE WAS PRESENT. THE PT WAS TREATED WITH DUODERM GCF ON THE ULCER (LEFT LEG) SAF-GEL AND FLEXIDRESS ON BOTH LOWER LEGS. THE SAME DRESSINGS WERE RE-APPLIED ON (B)(6) 2013. ON (B)(6) 2013, THE PT HAD AN INCREASE IN EDEMA IN THE LOWER RIGHT LEG ALONG WITH HEAT, REDNESS,SWELLING, RASH, AND SLOUGH (DIAMETER OF 20X20 CM). ON THE LOWER LEFT LEG THE ULCER WAS STILL PRESENT (5X4 CM) ALONG WITH FIBRINOID TISSUE DECREASE, INCREASED ERYTHEMA, PAIN, EDEMA, AND ITCHING SO THE FLEXIDRESS AND SAF-GEL WERE DISCONTINUED. THE PT ALSO HAD REDNESS, SWELLING AND ITCHING ON THEIR FACE AND ARMS. BOTH OF THE PT'S WOUNDS WERE REDRESSED WITH PETROLEUM JELLY AND GAUZE AND THE PT WAS TOLD TO GO TO THE EMERGENCY ROOM FOR A MEDICAL EVALUATION. ON (B)(6) 2013, THE PT SAW A DOCTOR AND THEY WERE TOLD THEY WERE HAVING AN ALLERGIC REACTION TO FLUNARIZINE WHICH THEY TOOK ON (B)(6) 2013. THE PT WAS TAKEN OFF OF THE FLUNARIZINE AND STARTED TAKING CEPHALEXIN 500MG EVERY 6 HOURS FOR 10 DAYS ALONG WITH IBUPROFEN. ON (B)(6) 2013, IT WAS REPORTED THE PT STATED THEY BEGAN TAKING CEPHALEXIN AND THE IBUPROFEN AND HAD A DECREASE IN INFLAMMATION AND RASH (INCLUDING ON THEIR HANDS AND FACE). ON (B)(6) 2013, THE PT WAS RESTARTED ON THE FLEXIDRESS, SAF-GEL, AND DUODERM CGF ON LOWER LEFT LEG AND AQUACEL (15X15 CM) AND FLEXIDRESS ON THE RIGHT LEG. THE PT RECEIVED TWO ADDITIONAL TREATMENTS ON (B)(6) 2013. ON (B)(6) 2013, THE PT RETURNED TO (B)(6) MEDICAL CARE AND STATED THEY WERE EXPERIENCING PAIN, HEAT, AND REDNESS. THE PT'S LEGS WERE TREATED WITH VASELINE AND COVERED WITH GAUZE. THE ULCER ON THE LEFT LEG WAS TREATED WITH DUODERM CGF AND GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491997 SAF-GEL - WOUND DRESSING W/ ALGINATE HYDROGEL WOUND AND BURN DRESSING NAE ACCUPAC, INC 145730 1952A3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DUODERM CGF| (B)(6) 2013]| [TX DATE: (B)(6) 2013,| AQUACEL| FLEXISEAL