BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROMOGRAN MATRIX

    MDR report key: 2249763 · Received September 5, 2011

    Report

    Report Number
    3007663067-2011-00004
    Event Type
    Other
    Date Received
    September 5, 2011
    Date of Event
    August 5, 2011
    Report Date
    September 5, 2011
    Manufacturer
    SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K014129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THE BATCH MET ALL RELEASE CRITERIA. FOLLOWING THE CLEANING OF THE WOUND WITH STERILE WATER THE NURSE SAID SHE DIDN'T LIKE THE LOOKS OF THE WOUND BECAUSE YELLOW TISSUE HAD FORMED. THE NURSE DID NOT APPLY ANYTHING TO THE WOUND. OVER THE COURSE OF SEVERAL DAYS, THE WOUND GREW LARGER AND WAS MORE YELLOW IN COLOR. PT CONTINUED TO COMPLAIN OF PAIN AND PAIN HAD SPREAD TO THE PT'S TOE. ON (B)(6) (PT'S DAUGHTER) TOOK HER MOTHER TO THE ER OF THE HOSP. THE HOSP TOOK PT'S VITAL SIGNS AND A CULTURE OF THE WOUND. THEY ADVISE (B)(6) TO WASH THE WOUND TWICE A DAY AND ROLL A Q-TIP OVER THE YELLOW TISSUE. (B)(6) MENTIONED THAT WHEN PROMGRAN WAS FIRST APPLIED TO THE WOUND, THE WOUND HAD SLIGHT YELLOW TISSUE SHOWING.

    Description of Event or Problem · 1

    NURSE PUT ON PT'S FOOT ULCER WOUND DRESSING MATRIX COVERED WITH MEPITEX TAPE. WITHIN 8 HRS, PT COMPLAINED OF BURNING. SHORTLY AFTER PT STATED SHE DID NOT FEEL WELL AND WAS DESCRIBED AS PALE IN COLOR, 10 HRS AFTER HAVING THE WOUND DRESSING MATRIX APPLIED, THE PT WAS IN SUCH PAIN HER DAUGHTER CALLED THE EMERGENCY NURSE. THEY DID NOT RESPOND UNTIL THE NEXT DAY WHEN 2 NURSES VISITED. AFTER REMOVING THE TAPE, IT WAS OBSERVED THAT THE WOUND DRESSING MATRIX HAD NOT DISSOLVED. APPROXIMATELY THE NEXT DAY, THE WOUND WAS CLEANED WITH STERILE WATER AND IT DISSOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOGRAN MATRIX WOUND DRESSING FRO SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED 1110/2/1/3

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Other