BEUDAMED
    FDA Adverse Event Death Summary report: N

    IDRT-TS 8X10 SINGLE DOMESTIC

    MDR report key: 8060864 · Received November 12, 2018

    Report

    Report Number
    1121308-2018-00095
    Event Type
    Death
    Date Received
    November 12, 2018
    Report Date
    October 15, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    MDD
    PMA / PMN Number
    P900033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THERE WERE TWO ISSUES REPORTED WITHIN THE COMPLAINT: RIGHT FOOT: PRODUCT DID NOT TAKE AND NEVER ADHERED AND WAS PUSSED OUT. LEFT FOOT: RESULTED IN PSEUDOMONAS. PER ADDITIONAL INFORMATION PROVIDED, PATIENT WAS NOT IN GOOD HEALTH AND WAS ON DIALYSIS. FOR BOTH CASES, IT IS DIFFICULT TO PINPOINT THE EXACT ROOT CAUSE. PER DHR REVIEW, ALL PRODUCTS WERE RELEASED BASED ON PASSING OF ALL IN PROCESS AND FINISHED GOODS CRITERIA. THIS INCLUDES ENSURING THAT STERILE PRODUCT GETS TO THE CUSTOMER. THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL TEST RESULTS PASSED THE PROCEDURAL SPECIFICATIONS, AND THERE WERE NO DEFECTS OBSERVED IN STERILITY OF PRODUCT THAT CAN LEAD TO INFECTION ON ONE FOOT AND ¿FAILURE TO TAKE¿ ON ANOTHER FOOT. THE FAILURE IS UNCONFIRMED, AS THERE WAS NO PRODUCT RETURNED FOR THIS COMPLAINT; IT WAS USED DURING SURGERY. THEREFORE, FAILURE ANALYSIS COULD NOT BE PERFORMED. BASED ON THE RISK DOCUMENTATION REVIEW, THE MOST PROBABLE ROOT CAUSE CAN BE THAT THE ENVIRONMENT POST APPLICATION WAS INADEQUATE FOR WOUND HEALING FOR BOTH CASES. IN ADDITION, THE PATIENT WAS NOT IN GOOD HEALTH (DIALYSIS) DURING APPLICATION OF PRODUCT ON BOTH RIGHT FOOT AND LEFT FOOT SO OTHER HEALTH ISSUES COULD ALSO HAVE RESULTED IN INFECTION (PSEUDOMONAS) ON LEFT FOOT POST APPLICATION AND FAILURE OF PRODUCT TO TAKE ON RIGHT FOOT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE DOCTOR ON 06-DEC-2018, STATING THE PATIENT HAD A FULL THICKNESS SCALDING BURN ON BOTH FEET, EXTENDED TO MID-CALF WITH A TOTAL SURFACE BODY AREA OF 5%. NO OTHER PRODUCTS WERE CONCURRENTLY USED ON THE PATIENT.

    Description of Event or Problem · 1

    1 OF 2 REPORTS - OTHER MFG REPORT NUMBER: 1121308-2018-00096. IT WAS REPORTED THAT THE PATIENT HAD IDRT APPLIED TO BILATERAL FEET DUE TO A BURN INJURY ON (B)(6) 2018. THE LEFT FOOT EVENTUALLY GOT INFECTED WITH PSEUDOMONAS AND THE PRODUCT WAS REMOVED ON (B)(6) 2018. PATIENT GOT SEPSIS AND PASSED AWAY. THE SPECIFIC DATE OF DEATH WAS NOT PROVIDED, ONLY THAT WAS ON THE WEEK OF (B)(6). THE DOCTOR BELIEVES THAT THERE WAS FURTHER BURN CONVERSION POST APPLICATION WHICH CONTRIBUTED TO THE INFECTION.

    Description of Event or Problem · 1

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900801 IDRT-TS 8X10 SINGLE DOMESTIC IDRT-TS MDD INTEGRA LIFESCIENCES CORPORATION 2282097

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death