BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDRT, UNKNOWN

    MDR report key: 14999603 · Received July 13, 2022

    Report

    Report Number
    1121308-2022-00082
    Event Type
    Injury
    Date Received
    July 13, 2022
    Report Date
    September 16, 2022
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    MDD
    PMA / PMN Number
    P900033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED; HOWEVER, THE MOST PROBABLE ROOT CAUSE IS MOST LIKELY ATTRIBUTABLE TO THE UNDERLYING HEALTH CONDITIONS OF THE PATIENTS WITHIN THE STUDY. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBERS: 1121308-2022-00083 AND 1121308-2022-00081. ANNALS OF BURNS AND FIRE DISASTERS PUBLISHED (2014) "INTEGRA IN BURNS RECONSTRUCTION: OUR EXPERIENCE AND REPORT OF AN UNUSUAL IMMUNOLOGICAL REACTION." "LIMITED AVAILABILITY OF AUTOLOGOUS DONOR SITES POSES SIGNIFICANT CHALLENGES FOR SOFT-TISSUE RECONSTRUCTION IN SEVERE AND COMPLEX BURNS. INTEGRA IS A BI-LAYERED DERMAL REGENERATION TEMPLATE (DRT) WHICH HAS PLAYED A SIGNIFICANT ROLE IN SOFT TISSUE RE­CONSTRUCTION SINCE ITS INITIAL USE FOR FULL-THICKNESS BURN DEFECTS. THE PURPOSE OF THIS STUDY IS TO REPORT OUR INSTITUTIONAL EXPERIENCE OF INTEGRA IN BURNS MANAGEMENT OVER A 4-YEAR PERIOD AND HIGHLIGHT AN UNUSUAL REACTION TO ITS SECOND APPLICATION. TWENTY-FOUR CASES UNDERWENT INTEGRA RESURFACING FOR BURN MANAGEMENT FROM SEPTEMBER 2007 TO AUGUST 2011. DATA ON PATIENT DEMOGRAPHICS, INCLUDING CO-MORBIDITIES, INDICATIONS, OPERATIVE DATA, COMPLICATIONS, SECONDARY RECONSTRUCTION AND OUTCOMES WERE RECORDED. INTEGRA WAS USED IN 24 PATIENTS ON 37 ANATOMICAL SITES. ONE PATIENT DIED 3 WEEKS AFTER INJURY AND FIRST STAGE OF INTEGRA APPLICATION, AND WAS THEREFORE EXCLUDED FROM THE STUDY. SPLIT-THICKNESS SKIN GRAFTING WAS PERFORMED WITHIN AN AVERAGE OF 23 DAYS (WITH A RANGE OF 7-55 DAYS) AND MEAN GRAFT TAKE WAS 87% (WITH A RANGE OF 75-100%). FIVE CASES OF LOCAL INFECTION AT THE GRAFT SITE WERE RECORDED. THE AVERAGE LENGTH OF HOSPITAL STAY WAS 47 DAYS (WITH A RANGE OF 1-162 DAYS). THE MEAN FOLLOW-UP TIME WAS 17 MONTHS (WITH A RANGE OF 9-34 MONTHS). OVERALL, OUR EXPERIENCE WITH DRT WAS MIXED, THAT IS TO SAY WE FOUND IT SATISFACTORY WITH ACUTE BURNS RESURFACING BUT VERY GOOD WITH SECONDARY RECONSTRUCTION. THE MAIN ADVANTAGE OF INTEGRA IS ITS IMMEDIATE AVAILABILITY IN UNLIMITED QUANTITIES FOR SOFT-TISSUE RECONSTRUCTION IN MAJOR AND COMPLEX BURNS. THE MAIN DRAWBACKS ARE FINANCIAL IMPLICATIONS, TWO­ STAGE PROCEDURE, COMPLEX WOUND CARE AND RISK OF INFECTION. WE BELIEVE THAT INTEGRA CAN BE CONSIDERED AS A PROMISING MODALITY IN BURNS MANAGEMENT." "OF THE 23 PATIENTS, 14 WERE FEMALE AND 9 MALE, WITH AGES RANGING FROM 4-73 YEARS (GIVING A MEAN OF 28 YEARS). INTEGRA TM WAS USED IN ACUTE BURNS IN 15 ( 66%) AND SECONDARY BUM RECONSTRUCTION IN 8 (34%) CASES. INTEGRA WAS USED ON 37 ANATOMICAL SITES. COMMON SITES OF APPLICATION WERE THE UPPER LIMB 17 CASES (45%), TORSO 13 (36%), LOWER LIMB 6 (16%) AND HEAD AND NECK 1 (3%). THE LARGEST TOTAL BODY SURFACE AREA (TBSA) COVERED WITH LNTEGRA IN ACUTE BURNS WAS 64 PERCENT. TWENTY­ THREE PATIENTS UNDERWENT SECOND-STAGE SKIN GRAFTING. THE MEAN TIME FROM INTEGRA TM TO GRAFTING WAS 23 DAYS (WITH A RANGE OF 7- 55 DAYS) AND MEAN GRAFT TAKE WAS 87% (WITH A RANGE OF 75-100%). INTEGRA FAILED TO TAKE IN TWO PATIENTS. OF THESE, ONE HAD COMPLETE FAILURE ( EXCISION 20% TBSA TRUNK) AND RE­QUIRED FURTHER INTEGRA RESURFACING ONE WEEK LATER, ACHIEVING 90% TAKE, WHILST THE SECOND PATIENT HAD 100% TAKE ON ONE LIMB BUT COMPLETE FAILURE ON THE OTHER LIMB. WE RECORD­ED FIVE LOCAL INFECTIONS AT THE GRAFT SITE. FOUR PATIENTS GREW (B)(6), WHILST PSEUDOMONAS, COLIFORMS AND STAPHYLOCOC­CUS AUREUS WERE OTHER COMMON SPECIES. AVERAGE LENGTH OF STAY IN HOSPITAL WAS 47 DAYS (WITH A RANGE OF 1-162 DAYS). THREE PATIENTS WHO UNDERWENT IN­TEGRA RESURFACING FOR ACUTE BURNS REQUIRED SECONDARY SUR­GERY FOR SCAR CONTRACTURE RELEASE. THE MEAN FOLLOW-UP TIME WAS 17 MONTHS. OVERALL, WE ACHIEVED ADEQUATE WOUND COV­ERAGE IN OUR COHORT." CASE OF INTEREST: A 40-YEAR-OLD FEMALE SUSTAINED MAJOR BURNS DURING HER CHILDHOOD AND REQUIRED MULTIPLE PROCEDURES FOR BURNS MAN­AGEMENT. IN HER THIRD DECADE, SHE UNDERWENT RELEASE OF A BURN CONTRACTURE AND RESURFACING WITH INTEGRA TO BOTH THIGHS. SEVEN YEARS LATER, FURTHER INTEGRA RESURFACING FOR SCAR CONTRACTURE RELEASE TO THE UPPER ABDOMEN WAS REQUIRED. THE GRAFT TAKE WAS EXCELLENT WITH A SATISFACTORY FINAL OUT­COME. UNFORTUNATELY, THE PATIENT WAS READMITTED WITHIN 6 WEEKS WITH SWOLLEN PAPULONODULAR ERYTHEMATOUS AREAS TO BOTH THIGHS, CORRESPONDING TO THE PREVIOUS INTEGRA SITE. INTERESTINGLY, THE RECENT GRAFT SITES ON THE UPPER ABDOMEN WERE ENTIRELY NORMAL. THE MAJORITY OF INVESTIGATIONS WERE UNREMARKABLE, EXCEPT ELEVATED C REACTIVE PROTEIN AND EOSINOPHILS WITH NORMAL WHITE BLOOD CELLS ON PERIPHERAL BLOOD FILM. WOUND SWABS TAKEN FROM HER THIGHS AND SENT FOR CULTURE FAILED TO IDENTIFY A CAUSATIVE MICROBIAL PATHOGEN AND NO RESPONSE WAS ACHIEVED WITH ANTIBIOTIC USAGE. INCISION BIOPSIES SHOWED INFLAMMATORY PROCESS AT MID-DEEP DERMAL LAYERS. THE PATCH TEST AND IMMUNOLOGICAL STUDIES WERE NEGATIVE FOR HYPERSENSITIVITY REACTION, ALTHOUGH THE PATIENT RESPONDED TO TOPICAL STEROIDS. SHE HAD A SLOW BUT PROTRACTED RECOVERY . THIS REPORT IS FOR ADVERSE EVENT TO INCLUDE: RESURFACING/REVISION SURGERY, SWOLLEN PAPULONODULAR ERYTHEMATOUS, AND ELEVATED C REACTIVE PROTEIN.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772008 IDRT, UNKNOWN INTEGRA MDD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown