BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA MESHED DERMAL REGENERATION TEMPLATE 4X5 DOMESTIC

    MDR report key: 19430497 · Received May 30, 2024

    Report

    Report Number
    1121308-2024-00024
    Event Type
    Injury
    Date Received
    May 30, 2024
    Report Date
    April 28, 2025
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    MDD
    PMA / PMN Number
    P900033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H11. THE IMDRT (ID MDRT4051) WAS NOT RETURNED FOR EVALUATION (REMAINS IMPLANTED); THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED; HOWEVER, THE MOST LIKELY CAUSE IS THE UNDERLYING CONDITION OF THE PATIENT AS THE COMPLAINT INDICATED THAT, ¿THE PATIENT UNDERLYING CONDITION OF BURN WOUNDS COULD BE A RISK FACTOR TO THE REPORTED EVENTS¿. 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

    6 OF 10 REPORTS: SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS. OTHER MFG REPORT NUMBERS: 1121308-2024-00019. 1121308-2024-00020. 1121308-2024-00021. 1121308-2024-00022. 1121308-2024-00023. 1121308-2024-00025. 1121308-2024-00026. 1121308-2024-00027. 1121308-2024-00028. A FACILITY REPORTED A 72-YEAR-OLD FEMALE PATIENT WHO EXPERIENCED SEPSIS, INFECTION AND DEVICE INEFFECTIVE DURING THE USE OF IMDRT (MESHED DERMAL REGENERATION TEMPLATE) FOR BURN WOUND. CONCURRENT CONDITION WAS REPORTED AS BURN WOUND. NOT REPORTED: PATIENT MEDICAL HISTORY, PAST MEDICATION, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION. ON AN UNKNOWN DATE, THE PATIENT WAS APPLIED WITH IMDRT ON BURN WOUNDS AND SHE IT DID NOT INTEGRATE WITH WOUNDS, IT DID NOT HEAL, AND SHE EXPERIENCED INFECTION THAT CONTRIBUTED TO SEPSIS. AT THE TIME OF THE REPORTING, THE OUTCOME OF THE EVENTS SEPSIS, INFECTION, DID NOT INTEGRATE WITH WOUNDS/IT DID NOT HEAL WAS UNKNOWN. NO RELEVANT LAB DATA WAS REPORTED. THE ACTION TAKEN WITH IMDRT: WAS DISCONTINUED/REMOVED. THE CASE SERIOUSNESS WAS REPORTED BY THE REPORTER AS: REQUIRED INTERVENTION. THIS CASE WAS VERIFIED BY OTHER HEALTH CARE PROFESSIONAL/ PHYSICIAN. THERE IS LIMITED INFORMATION AVAILABILITY REGARDING CO-SUSPECT AND CONCOMITANT MEDICATION, RELEVANT MEDICAL HISTORY, AND LAB DATA TO ASSESS COMPLETE CAUSALITY. PATIENT UNDERLYING CONDITION OF BURN WOUNDS COULD BE A RISK FACTOR TO THE REPORTED EVENTS. ¿WE APPLIED INTEGRA OVER THE WOUNDS. THE INTEGRA DID NOT INTEGRATE WITH THE WOUNDS. UNDERNEATH THE INTEGRA, THERE WAS INFECTION. HENCE, IT HAD TO BE REMOVED. IT DIDN'T HEAL AND THIS CONTRIBUTED TO SEPSIS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225352 INTEGRA MESHED DERMAL REGENERATION TEMPLATE 4X5 DOMESTIC INTEGRA MESHED DERMAL REGENERATION TEMPLATE MDD INTEGRA LIFESCIENCES CORPORATION 6855425

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention