BEUDAMED
    FDA Adverse Event Death Summary report: N

    IDRT, UNKNOWN

    MDR report key: 10542105 · Received September 16, 2020

    Report

    Report Number
    1121308-2020-00047
    Event Type
    Death
    Date Received
    September 16, 2020
    Report Date
    August 26, 2020
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    MDD
    PMA / PMN Number
    P900033
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. A MEDICAL ASSESSMENT (MA) WAS COMPLETED FOR THIS COMPLAINT. THE MA CONCLUSION STATES THAT ¿SEPSIS AND INFECTION ARE KNOWN ADVERSE EVENTS WITH IDRT. INFECTION UNDER THE MEMBRANE MAY BE DIFFICULT TO IDENTIFY VISUALLY AND TSS MAY OCCUR WITHOUT THE PRESENCE OF AN INVASIVE INFECTION. IT IS IMPORTANT TO FOLLOW PROPER MEDICAL PROCEDURES AND MONITOR FOR SIGNS AND SYMPTOMS OF INFECTIONS WITH IDRT USE. METHODS FOR PREVENTING INFECTIONS SHOULD BE FOLLOWED. THE AUTHORS REFERENCE THE POTENTIAL BENEFITS OF PROPHYLACTIC NASAL MUPIROCIN OR CHLORHEXIDINE TO CONTROL NASAL BACTERIA CARRIAGE IN THIS CASE.¿ 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

    N/A

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A (B)(6)-YEAR-OLD EPILEPTIC FEMALE SUSTAINED 30% TBSA FULLTHICKNESS FLAME BURNS TO HER FACE, NECK AND CHEST. THESE HAD BEEN EXCISED AND AUTOGRAFTED ACUTELY. SHE SUBSEQUENTLY REQUIRED FOUR SCAR REVISION PROCEDURES, INCLUDING FREE TISSUE TRANSFER TO THE NECK. SHE CAME TO FURTHER SCAR RELEASE OF THE NECK AND ONE AXILLA, AND THE DEFECTS THAT RESULTED WERE RECONSTRUCTED WITH INTEGRATM. IN THE FIRST STAGE, DRY FULLTHICKNESS SKIN DEFECTS WERE COVERED WITH INTEGRATM, SECURED TO THE WOUND EDGES WITH STAPLES, AND DRESSED WITH TELFACLEARTM, FOUR LAYERS OF STERILE GAUZE SOAKED IN 0.5% SILVER NITRATE SOLUTION, AND NETALASTTM. IRRIGATION TUBES WERE INCORPORATED INTO THE GAUZE TO ALLOW REGULAR INSTILLATION OF FURTHER SILVER NITRATE SOLUTION. THREE- TO FOUR-HOURLY IRRIGATION OF THE DRESSINGS WITH 0.5% SILVER NITRATE SOLUTION KEPT THE DRESSINGS MOIST AND REPLENISHED WITH ACTIVE ANTIMICROBIAL SILVER. ON THE FIFTH POST-OPERATIVE DAY, THE PATIENT WAS DISCHARGED HOME WITH ORAL ANTIBIOTIC PROPHYLAXIS. ON THE NINTH POST-OPERATIVE DAY, THE PATIENT WAS READMITTED WITH A FEVER OF 41 C AND NAUSEA. ON REMOVAL OF HER DRESSINGS, THE INTEGRATM WAS ADHERENT EXCEPT IN TWO SMALL AREAS EACH APPROXIMATED TO ONE CENTIMETRE SQUARED OF THE AXILLA. THESE WERE DEROOFEDTHERE WAS NO UNDERLYING PUS. SERUM HAEMOGLOBIN WAS 13.9 G/DL, WHITE CELL COUNT 15 X 10(9)/L, PLATELETS 150,000MM3, BLOOD UREA 16.1 MMOL/L AND CREATININE 264 MMOL/L. WOUND SWABS WERE TAKEN FOR MICROSCOPY, CULTURE, AND SENSITIVITIES, AND INTRAVENOUS FLUCLOXACILLIN, GENTAMICIN, AND METRONIDAZOLE COMMENCED. OVER THE FOLLOWING 2 H THE PATIENT DETERIORATED WITH DIFFUSE ERYTHRODERMA OF FACE AND TRUNK, A SYSTOLIC BLOOD PRESSURE LESS THAN 90 MMHG, DECREASING URINE OUTPUT, AND INCREASING METABOLIC ACIDOSIS. BY THIS TIME SERUM HAEMOGLOBIN HAD FALLEN TO 9.4 G/DL, WHITE CELL COUNT WAS 13.5X10(9)/L, PLATELETS 120,000MM3. HEPATIC FUNCTION WAS DERANGED WITH A SERUM BILIRUBIN OF 43 MMOL/L, ALKALINE PHOSPHATASE 88 IU/L, ASPARTATE TRANSAMINASE 141 IU/ L, ALANINE AMINOTRANSFERASE 67 IU/L, AN INTERNATIONAL NORMALIZED RATIO (INR) OF 1.57, AND AN APTT OF 56. THE PATIENT WAS INTUBATED, VENTILATED, AND TRANSFERRED TO THEATRE FOR COMPLETE WOUND DEBRIDEMENT. ONCE AGAIN, THERE WAS NO EVIDENCE OF PUS. RESUSCITATION FAILED FOLLOWING A POST-OPERATIVE CARDIOPULMONARY ARREST. BLOOD CULTURES WERE STERILE. SAMPLES TAKEN AT OPERATION OF THE EXCISED INTEGRATM GREW (B)(6), PHAGE TYPE E-16. THE TSST-1 GENE WAS DEMONSTRATED BY POLYMERASE CHAIN REACTION AMPLIFICATION, AND TSST-1 PRODUCTION WAS DEMONSTRATED BY REVERSE PASSIVE LATEX AGGLUTINATION. A POST-MORTEM EXAMINATION AND SUBSEQUENT CORONERS INQUEST CONFIRMED THAT THE PATIENT DIED FROM TOXIC SHOCK SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004442 IDRT, UNKNOWN INTEGRA MDD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death