BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMATRIX 6X6

    MDR report key: 18255778 · Received December 1, 2023

    Report

    Report Number
    MW5148667
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    June 27, 2019
    Report Date
    November 30, 2023
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    KGN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    5/30: L LATERAL LEG WOUND. WOUND BED REMAINS PRIMARILY PINK BUT AGAIN SEEMS TO HAVE A BIT MORE PALE SUBCUTANEOUS TISSUE/ FASCIA PRESENT, THE TENDON APPEARS TO BE A BIT MORE COVERED. DEBRIDEMENT PERFORMED TODAY PRIOR TO PLACEMENT OF PRIMATRIX DERMAL MATRIX GRAFT. SMALL DRAINAGE. PRIMATRIX #1 PLACED: GRAFT SIZE: 6CMX 6CM GRAFT LOT#: 1811102 EXPIRATION DATE: 02/28/2023 SALINE LOT#: 8362826 EXPIRATION DATE: 12/31/2021 6/6: NO SIGN OF INFECTION. WOUND IS APPEARS TO BE MORE COVERED WITH GRANULATION BUDS. PRIMATRIX #2 PLACED GRAFT SIZE: 6CM X 6CM GRAFT LOT#:1811102 EXPIRATION DATE: 2023-02-28 SALINE LOT#: 9018542 EXPIRATION DATE: 2022-01-31 6/13: NO SIGNS OF INFECTION. THERE IS REMAINING GRAFT IN THE WOUND. NEGATIVE FOR CHILLS AND FEVER. 6/20: NO SIGNS OF INFECTION. GRAFT INCORPORATED, NO GRAFT AVAILABLE. COLLAGEN GEL PLACED 6/27: NO SIGNS OF INFECTION. PRIMATRIX #3 PLACED. GRAFT SIZE: 6X6 GRAFT LOT#: 1903124 EXPIRATION DATE: 06/30/2023 SALINE LOT#: 9074617 EXPIRATION DATE: 02/28/2022 7/3: PRIMATRIX GRAFT - LARGE PORTION REMAINS INTACT TODAY. NO SIGNS OF INFECTION. NEGATIVE FOR FEVER AND CHILLS 7/11: THERE IS WHAT APPEARS TO BE MOIST LAYER OF GRAFT PRESENT IN SOME LOCATIONS TODAY. NO SIGNS OF INFECTION. CONTINUES TO PROGRESS. NEGATIVE FOR FEVER AND CHILLS 7/18: HIS WOUND WAS CLEANED TODAY AND IS SOMEWHAT HYPERGRANULAR, NONE OF HIS GRAFT REMAINS. NO SIGNS OF INFECTION. LOWER LEG/ANKLE INCREASED WITH SWELLING FROM LAST VISIT. SHARP DEBRIDEMENT PERFORMED. NEGATIVE FOR FEVER AND CHILLS. 7/25: HIS WOUND IS NO LONGER HYPERGRANULAR. NO SIGNS OF INFECTION. NEGATIVE FOR FEVER/CHILLS 8/1: HE FEELS THAT HE HAD INCREASED DRAINAGE IN THE BEGINNING OF THE WEEK THAT WAS SEROUS AND IT DECREASED OVER THE LAST 2 DAYS. INITIAL WOUND HAS IMPROVED IN SIZE BUT THE NEW AREA OF ULCERATION IS LARGER AND LOOKS MORE LIKE A BOGGY GRANULOMA. I THINK THE NEW LESION MAY BE ANOTHER SKIN MANIFESTATION OF HIS SCLERODERMA. NEGATIVE FOR FEVER/CHILLS. NO REDNESS OR ERYTHEMA. AREA PROTRUDES 4MM FROM SURROUNDING SKIN. 8/8: NO HYPERGRANULAR TISSUE; DRAINAGE IS IMPROVED. NEGATIVE FOR FEVER/CHILLS. NO REDNESS OR ERYTHEMA. 8/15: IT IS PALE PINK WITH FLAT GRANULATION BED - WILL TREAT WITH SHARP DEBRIDEMENT TODAY TO STIMULATE. NEGATIVE FOR FEVER/CHILLS. TACHYCARDIC. 8/22: SHARP DEBRIDEMENT. NEGATIVE FOR CHILLS/FEVER. 8/29: THERE IS ONLY A SMALL OPEN ULCER REMAINING. IT IS PALE PINK WITH FLAT GRANULATION BED - GOOD EPITHELIALIZATION FROM THE PERIPHERY. NEGATIVE FOR CHILLS/FEVER. TACHYCARDIC. 9/12: WOUND IS HEALED. NEGATIVE FOR FEVER/CHILLS. TACHYCARDIC. NO FOLLOW UP WITH WOUND CARE FROM THIS POINT ON. RECALL OF PRIMATRIX 5/2023. REFERENCE REPORT: #MW5148665, #MW5148666.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205078 PRIMATRIX 6X6 WOUND DRESSING WITH ANIMAL-DERIVED MATERIAL(S) KGN INTEGRA LIFESCIENCES CORPORATION 1811102

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Other SALINE AND COLLAGEN GEL.