BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOUNDSEAL

    MDR report key: 3894098 · Received June 20, 2014

    Report

    Report Number
    1066421-2014-00001
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BIOLIFE, LLC
    Product Code
    FRO
    PMA / PMN Number
    K070520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL INTERNAL INVESTIGATION WAS INITIATED ON (B)(4) 2014. AN E-MAIL WAS SENT TO DR.(B)(6) ASKING FOR A MED OPINION BASE ON THE REPORT FROM THE CONSUMER.

    Description of Event or Problem · 1

    CONSUMER WAS AT HER DAUGHTER'S HOUSE ON (B)(6) 2014, IN THE KITCHEN CUTTING UP SWEET POTATOES WHEN SHE CUT HER THUMB. SHE DID NOT WANT TO GO TO THE ER SO SHE SENT HER BOYFRIEND TO (B)(6) TO GET BANDAGES AND SHE CAME HOME WITH SOME AS WELL AS WOUNDSEAL. SHE HAD HELD HAND UNDERRUNNING WATER AND THEN HELD PRESSURE WITH A PAPER TOWEL. APPLIED OUR PRODUCT PER INSTRUCTIONS AND IT WORKED VERY WELL TO STOP THE BLEEDING. SHE PROCEEDED TO GO TO WORK THE NEXT DAY AND RAVED ABOUT HOW GREAT OUR PRODUCT WAS ON TUESDAY HER THUMB WAS SWOLLEN AND PAINFUL. SHE WENT TO URGENT CARE WHERE THEY REMOVED THE BANDAGE, WOUNDSEAL AND CLEANED THE WOUND. THEN GAVE HER IV ANTIBIOTICS AND SENT HER HOME ON AUGMENTIN SHE WAS OUT BY NOON ON TUESDAY. BY TUESDAY LATER IN THE DAY SHE HAD MORE PAIN, SHE CALLED HER PRIMARY CARE PHYSICIAN AND WENT BACK TO URGENT CARE. SHE HAD ON LONG SLEEVES AND WHEN THEY ROLLED IT UP SHE AND THEY SAW A LONG RED STREAK AND SENT HER IMMEDIATELY TO THE ER, SHE WENT TO THE HOSP. THREE NIGHTS, VANCOMYCIN, UNASYN, AND A SURGICAL PROCEDURE (SHE SAID THEY DID NOT NUMB IT AND SHE FELT EVERYTHING). (B)(6) WAS FOUND AND SPLINT WAS APPLIED. SHE WAS HOME ON FRIDAY. SHE IS BACK TO WORK WITH AUGMENTIN AND BACTRIM ANTIBIOTICS AND WAS DIAGNOSED WITH CELLULITIS. SHE STATED THAT OUR PRODUCT "DID NOT GIVE HER THE INFECTION BUT WOULD NOT LET IT OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364051 WOUNDSEAL WOUNDSEAL FRO BIOLIFE, LLC SP310 311401

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization