BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA ARTIFICIAL SKIN

    MDR report key: 241686 · Received September 21, 1999

    Report

    Report Number
    1121308-1999-00014
    Event Type
    Injury
    Date Received
    September 21, 1999
    Date of Event
    May 22, 1999
    Report Date
    September 3, 1999
    Manufacturer
    INTEGRA LIFESCIENCE CORP.
    Product Code
    MDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DATE OF BURN INJURY WAS 05/14/1999. INTEGRA ARTIFICIAL SKIN WAS PLACED ON BURN INJURY SITE ON PATIENT'S CHEST ON 05/19/1999. BURN INJURY AREA TOTALED 60.5% OF BODY SURFACE. INTEGRA ARTIFICIAL SKIN WAS PLACED ON 12.1% OF BODY SURFACE. BURN SITES ADJACENT TO INTEGRA ARTIFICIAL SKIN WERE NOT COVERED WITH ANY GRAFT. ON 05/22/1999 PATIENT SUFFERED SEVERE BRADYCARDIA WHICH REQUIRED CHEST COMPRESSIONS APPLIED TO THE AREA OF INTEGRA ARTIFICIAL SKIN APPLICATION. USER FACILITY NOTED INFECTION OF CHEST SITE ON 05/22/1999. CULTURES OF CHEST AREA TAKEN ON 05/22/1999 WERE POSITIVE FOR P MIRABILIS, P AEURGINOSA, S AUREUS, AND ENTEROCOCCUS. BLOOD, URINE AND CATHETER CULTURES TAKEN ON 05/22/1999 WERE ALL POSITIVE FOR SIMILAR ORGANISMS AS THE CHEST SITE. NO CULTURES WERE TAKEN PRIOR TO APPLYING INTEGRA ARTIFICIAL SKIN. NO CULTURES OF OTHER BURN SITES WERE TAKEN. ON 05/24/1999 THE INTEGRA WAS REMOVED AND AREA TREATED WITH SULFAMYLON CREAM AND SOLUTION. ALLOGRAFT WAS PLACED ON SITE ON 05/27/1999. THERE WAS NO INDICATION OF WHETHER ALLOGRAFT WAS SUCCESSFUL AS PATIENT EXPIRED SECONDARY TO RENAL/HEPATIC FAILURE, AND CARDIAC PROBLEMS. MD STATED THAT PATIENT DEATH WAS NOT RELATED TO INTEGRA ARTIFICIAL SKIN, BUT WAS RELATED TO A PRE-EXISTING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA ARTIFICIAL SKIN Implant DERMAL REGENERATION TEMPLATE MDD INTEGRA LIFESCIENCE CORP. IAS-810 8600200

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention 20. MVI WITH FOLATE (05/18/1999 TO UNK),| 5. FENTANYL (05/14/1999 TO UNK),| 19. BISCODYL (05/18/1999 TO UNK),| 7. LORAZEPAM (05/14/1999 TO UNK),| 8. MIDAZOLAM (05/14/1999 TO UNK),| 15. SILVER SULFADIAZINE (05/15/1999 TO UNK),| 17. DIPHENHYDRAMINE (05/16/1999 TO UNK),| 21. REGLAN (05/18/1999 TO UNK),| 24. CALCIUM GLUCONATE (05/19/1999 TO UNK),| 26. LACTATED RINGERS (05/19/1999 TO UNK),| 28. ATROPINE (05/20/1999 TO UNK),| 6. KP04 (05/14/1999 TO UNK),| 32. BACITRACIN (05/22/1999 TO UNK),| 10. ACETAMINOPHEN (05/15/1999 TO UNK),| 23. ALBUTEROL (05/19/1999 TO UNK),| 3. VALIUM (05/14/1999 TO UNK),| 14. MORPHINE SULFATE (05/15/1999 TO UNK),| 1. VERSED (05/14/1999 TO UNK),| 11. ATIVAN (05/15/1999 TO UNK), COLURE (05/15/1999| TO UNK), DOCUSATE (05/15/1999 TO UNK), HEPARIN| (05/15/1999 TO UNK),| 12. METOCLOPRAMIDE (05/15/1999 TO UNK),| 2. SUCCS (05/14/1999 TO UNK),| 33. PANCURONIUM (05/22/1999 TO UNK),| 29. PACKED CELLS (05/20/1999 TO UNK),| 18. NAPO4 (05/16/1999 TO UNK),| 16. VERSED (05/15/1999 TO UNK),| 27. SULFAMYLON POWDER (05/19/1999 TO UNK),| 9. MORPHINE (05/14/1999 TO UNK),| 22. VITAMIN C (05/18/1999 TO UNK),| 25. IPRATROPIUM BROMIDE (05/19/1999 TO UNK),| 30. RETINOL (05/21/1999 TO UNK),| 34. TROVAN (05/22/1999 TO UNK).| 31. ZINC (05/21/1999 TO UNK),| 13. MGSO4 (05/15/1999 TO UNK),| 4. MSO4 (05/14/1999 TO UNK),