BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDRT, UNKNOWN

    MDR report key: 10280846 · Received July 15, 2020

    Report

    Report Number
    1121308-2020-00024
    Event Type
    Injury
    Date Received
    July 15, 2020
    Report Date
    May 14, 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

    UPDATED FIELDS: D10, G4, G7, H2, H3, H6, H10. 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. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED.

    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

    EPLASTY PUBLISHED IN 2012 "EXTENSIVE SELF-HARM SCARRING: SUCCESSFUL TREATMENT WITH SIMULTANEOUS USE OF A SINGLE LAYER SKIN SUBSTITUTE AND SPLIT-THICKNESS SKIN GRAFT" OBJECTIVE: DELIBERATE SELF-HARM (DSH) RESULTING IN EXTENSIVE SKIN SCARRING IS A DIFFICULT CLINICAL PROBLEM AND IS COMMONLY ASSOCIATED WITH PHYSICAL AND SEXUAL ABUSE OR A KNOWN HISTORY OF MENTAL ILLNESS. IMMEDIATE HOSPITAL ATTENDANCE OFTEN ADDRESSES THE ACUTE WOUND AND CURRENT PSYCHOLOGICAL STATE OF PATIENTS; HOWEVER, ONGOING REGRET OF THESE RESULTING SCARS PRESENT A PROBLEM TO THE PATIENT AND CLINICIAN. DELIBERATE SELF-HARM TO THE SKIN LEAVES PERMANENT AND SOCIALLY UNACCEPTABLE SCARS IN ANATOMICALLY CONSPICUOUS AREAS AND RECOGNIZABLE TO OTHERS. THEREFORE, THE AIM WAS TO OFFER A TREATMENT TO CHANGE THESE SCARS TO THAT OF AN UNKNOWN ENTITY. METHODS: SIX PATIENTS WITH EXTENSIVE LINEAR SCARS COVERING MOST OF THE FOREARM RECEIVED SURGICAL RECONSTRUCTION. PATIENTS WERE FEMALE AGED BETWEEN 18 AND 47 YEARS. EACH PATIENT HAD A HISTORY OF PSYCHOSOCIAL PROBLEMS, AND EACH HAD UNDERGONE PSYCHIATRIC TREATMENT. AFTER AN IN-DEPTH CONSULTATION AND A FURTHER CLINICAL PSYCHOLOGICAL ASSESSMENT, EACH INDIVIDUAL WAS DEEMED SUITABLE FOR RECONSTRUCTIVE SURGERY. SCARS WERE EXCISED FROM THE FOREARM EN BLOCK, REMOVING THE MAJORITY OF THE AFFECTED AREA. SIMULTANEOUS USE OF A SINGLE LAYER SKIN SUBSTITUTE WAS USED, COVERED BY AN AUTOLOGOUS SPLIT-THICKNESS SKIN GRAFT. NEGATIVE PRESSURE WOUND THERAPY WAS THEN APPLIED IMMEDIATELY FOR 2 WEEKS AFTER SURGERY. RESULTS: THE ORIGINAL SCARS WERE SUCCESSFULLY CONVERTED TO A SOCIALLY AND COSMETICALLY ACCEPTABLE APPEARANCE. POSTOPERATIVE INFECTION DUE TO NEGATIVE PRESSURE WOUND THERAPY FAILURE IN ONE PATIENT WAS THE ONLY COMPLICATION REPORTED. AT THE AGE OF 18 YEARS, THIS PATIENT HAD A 3-YEAR HISTORY OF DSH FROM THE AGE OF 13 TO 16 YEARS. SCARS WERE MADE WITH RAZOR BLADES AND NOTED TO BILATERAL FOREARMS AND UPPER ARMS. SCAR RECONSTRUCTION WAS TO THE LEFT FOREARM, EXCISING THE BLOCK OF SCARRED TISSUE AND REPLACING THIS WITH SINGLE LAYER INTEGRA AND AN STSG TAKEN FROM THE LEFT UPPER INNER ARM. SHE DEVELOPED A PSEUDOMONAS AERUGINOSA INFECTION POSTOPERATIVELY DUE TO FAILURE OF THE NPWT DRESSING. AN EXPLANATION FOR THIS MAY BE DUE TO THE EXTENSIVE NATURE OF HER SCARS COVERING HER ENTIRE VOLAR FOREARM, WHICH REQUIRED THE NPWT TO BE APPLIED ACROSS BOTH HER WRIST AND ELBOW CREASE. A LACK OF SUFFICIENT SEAL LED TO MULTIPLE ATTEMPTS TO FIX THIS AND A FINAL ABANDONMENT OF USING NPWT. THIS INFECTION WAS TREATED WITH ORAL ANTIBIOTICS AND FREQUENT DRESSING CHANGES AND WAS RESOLVED WITHIN 7 DAYS. THIS RESULTED IN A 50% GRAFT LOSS, WHICH WAS SUBSEQUENTLY FOLLOWED WITH REAPPLICATION OF STSG TO AREAS OF LOST GRAFT TAKE. NO FURTHER NPWT WAS USED IN THE POST MANAGEMENT OF THIS CASE.¿ CONCLUSIONS: THIS CASE SERIES HIGHLIGHTS THE UTILITY OF AN INNOVATIVE TREATMENT FOR PATIENTS WITH DSH SCARRING RESULTING IN AESTHETIC, PSYCHOLOGICAL, AND FUNCTIONAL BENEFITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738455 IDRT, UNKNOWN INTEGRA MDD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1