BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDRT, UNKNOWN

    MDR report key: 10542261 · Received September 16, 2020

    Report

    Report Number
    1121308-2020-00048
    Event Type
    Injury
    Date Received
    September 16, 2020
    Report Date
    August 24, 2020
    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 · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER INFORMATION HAS 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. 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.

    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

    BRITISH ASSOCIATION OF PLASTIC, RECONSTRUCTIVE AND AESTHETIC SURGEONS. (2020) PUBLISHED, 'INTEGRA DERMAL REGENERATION TEMPLATE AS THE NIDUS OF STAPHYLOCOCCAL TOXIC SHOCK SYNDROME: A CASE REPORT'. THE LITERATURE DESCRIBES NUMEROUS SUCCESSFUL APPLICATIONS USING DERMAL REGENERATION TEMPLATES SUCH AS INTEGRA R. DESPITE WIDESPREAD USE FOR BURNS, TRAUMA, AND CHRONIC WOUNDS AMONG OTHERS, INTEGRA HAS ASSOCIATED COMPLICATIONS WHICH NEED CONTINUED INVESTIGATION. LARGE MULTI-CENTER STUDIES DESIGNED TO INVESTIGATE ITS SAFETY HAVE SHOWN THAT INFECTIONS ARE THE MOST COMMON COMPLICATIONS. IN THIS CASE REPORT, WE SHARE OUR EXPERIENCE WITH A PATIENT WHO DEVELOPED TOXIC SHOCK SYNDROME (TSS) FOLLOWING ABDOMINAL SCAR REVISION WITH INTEGRA. THE LITERATURE REVIEWED IDENTIFIED ONE REPORT OF TSS IN ASSOCIATION WITH INTEGRA USE, WHICH WAS FA- TAL. IN OUR CASE, THE PATIENT RECOVERED UNEVENTFULLY AS A RESULT OF EARLY RECOGNITION, EXPEDIENT DEBRIDEMENT, AND APPROPRIATE ANTIBIOTIC ADMINISTRATION. CASE REPORT: A 13-YEAR-OLD MALE WITH A HISTORY OF 18% BODY SURFACE AREA BURNS RANGING FROM THE STERNUM TO THE SUPRAPUBIC REGION PRESENTED WITH HYPERTROPHIC ABDOMINAL SCARS CAUSING DISCOMFORT AND SUBJECTIVE LIMITATION IN HIS ABILITY TO HYPEREXTEND HIS TORSO AND ARCH HIS BACK .DUE TO THE MASSIVE SIZE OF THE SCARS IN HIS ABDOMEN, TISSUE EXPANSION TO SERIALLY REMOVE THE SCARS WOULD HAVE BEEN OVERWHELMINGLY ARDUOUS, AND BOTH PATIENT AND PARENT WERE DISINTERESTED. A DECISION WAS THEN MADE TO ADDRESS THE HYPERTROPHIC AREAS, WHICH WERE EXCISED FROM THE BILATERAL AND MID ABDOMINAL WALL, WHICH CREATED A WOUND COVERED BY INTEGRA MEASURING 21 CM X 6 CM. THE MIDLINE SECONDARY DEFECT REQUIRED SKIN GRAFTING. THE RATIONALE IN STAGING REPAIR WITH INTEGRA FIRST WAS TO OFFER HIM A THICKER, SUPPLER SKIN COVERAGE. A WOUND VAC (KCI, SAN ANTONIO, TX, USA) WAS EMPLOYED AS A BOLSTER. HE WAS HOSPITALIZED FOR ONE WEEK FOR PAIN CONTROL AND DISCHARGED AFTER HIS FIRST WOUND VAC CHANGE. ON POSTOPERATIVE DAY 14, HIS VAC WAS CHANGED BY VISITING HOME HEALTH. TWO DAYS LATER, HE DEVELOPED A SEVERE HEADACHE, EMESIS, AND DIFFUSE FULL-BODY MACULAR ERYTHRODERMA. THE PATIENT ARRIVED AT THE OUTSIDE HOSPITAL¿S EMERGENCY DEPARTMENT (ED) AT 1 PM WITH FEVER (101.5 °F) AND TACHYCARDIA (138 BPM). HE WAS NORMOTENSIVE, AND HIS WBC WAS 21. UPON LIFE FLIGHT ARRIVAL 1 H LATER, HIS BLOOD PRESSURE WAS 94/47 DESPITE THE ADMINISTRATION OF A 2-LITER BOLUS AND THE FIRST DOSE OF BROAD-SPECTRUM ANTIBIOTICS. DURING TRANSPORT, LOW-DOSE EPINEPHRINE DRIP AND ADDITIONAL FLUID RESUSCITATION (1 LITER) WERE ADMINISTERED. AFTER ARRIVAL TO THE PEDIATRIC ICU AND 2 ADDITIONAL LITERS, HYPOTENSION RESOLVED BUT HE WAS STILL TACHYCARDIC AT 132. THE PATIENT UNDERWENT STANDARD SEPSIS WORKUP, WHICH INCLUDED A FULL-BODY EXAMINATION, NEGATIVE URINE, NEGATIVE BLOOD CULTURES, AND A NEGATIVE CHEST X-RAY. THE PLASTIC SURGERY TEAM EVALUATED THE PATIENT AT APPROXIMATELY 6 PM. THE MAJORITY OF THE INTEGRA GRAFT WAS INTACT EXCEPT FOR A 4 ×5 CM AREA AT THE EPIGASTRIC REGION, WHICH POSSESSED A GRAY- BROWNISH DISCOLORATION UNDER THE SILASTIC MEMBRANE. THERE WAS NO FRANK PURULENT DRAINAGE, EXQUISITE TENDERNESS, OR SURROUNDING CREPITUS. APPROXIMATELY 8.5 H FOLLOWING HIS INITIAL PRESENTATION TO HIS HOMETOWN¿S ED, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM WITH A BP OF 108/60, HEART RATE OF 121, AND RESPIRATORY RATE OF 26 AT 100% OXYGEN SATURATION ON ROOM AIR. UNHEALTHY TISSUE WAS SHARPLY EXCISED, AND APPROXIMATELY 30% (6 CM X 5 CM) OF THE INTEGRA GRAFT WAS REMOVED. HE WAS EXTUBATED, WEANED OFF VASOPRESSORS, AND TRANSFERRED OUT OF THE ICU THE FOLLOWING DAY. INTRAOPERATIVE INTEGRA TISSUE CULTURE GREW METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA). HE WAS TREATED WITH IV CLINDAMYCIN AND VANCOMYCIN FOR 4 DAYS, FOLLOWED BY A SWITCH TO CEFAZOLIN. HE UNDERWENT TWICE PER DAY DRESSING CHANGES, WHICH WAS CONDUCTED USING ADAPTIC GAUZE (JOHNSON &JOHNSON, NEW BRUNSWICK, NJ) COVERED BY 4 ×4S MOISTENED WITH 0.25% SODIUM HYPOCHLORITE. HAVE RETURNED TO THE OPERATING ROOM ON POSTOPERATIVE DAY 5 FOR MINOR DEBRIDEMENT AND WAS FOUND TO HAVE NO SIGNIFICANT TISSUE NECROSIS. 11 DAYS AFTER INITIAL DEBRIDEMENT, HE UNDERWENT SPLIT-THICKNESS SKIN GRAFTING TO BOTH THE DEBRIDED EPIGASTRIC AREA AND THE INTACT INTEGRA AND WAS PRESCRIBED TWO-WEEKS OF PO CEPHALOSPORINS. THE APPEARANCE OF THE PATIENT¿S FULLY HEALED AT 18-WEEK FOLLOW-UP. HE NO LONGER COMPLAINED OF RESTRICTION AT THE EPIGASTRIUM WHEN HYPEREXTENDING HIS CHEST AND REMAINS HEALED 10 MONTHS AFTER SKIN GRAFTING. CONCLUSION WHILE INTEGRA OFFERS CRUCIAL BENEFITS, SUCH AS A BETTER CHANCE FOR REVASCULARIZATION THAN DIRECT SKIN GRAFT IN CERTAIN SITUATIONS, THE SURGEON SHOULD BE AWARE THAT INFECTIOUS COMPLICATIONS ARE NOT UN- COMMON. THE RARE INCIDENCE OF TOXIC SHOCK SYNDROME SHOULD BE MENTIONED IN THE INFORMED CONSENT. PROVIDER¿S AWARENESS OF THIS POTENTIAL COMPLICATION IS PARAMOUNT WHEN ENCOUNTERING POSTOPERATIVE. HTTPS://DOI.ORG/10.1016/J.JPRA.2020.05.003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006606 IDRT, UNKNOWN INTEGRA MDD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1