BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. GRANUFOAM DRESSING

    MDR report key: 11940121 · Received June 4, 2021

    Report

    Report Number
    3009897021-2021-00120
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    March 24, 2021
    Report Date
    June 4, 2021
    Manufacturer
    KINETIC CONCEPTS, INC
    Product Code
    OMP
    PMA / PMN Number
    K133276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REGARDING THE ACTIV.A.C.¿ THERAPY SYSTEM SERIAL NUMBER VFSR11570: SERIAL #: VFSR11570; CATALOG #: 340020; UNIQUE IDENTIFIER (UDI) #: (B)(4). PKA/510K#: K201571 DEVICE MANUFACTURE DATE: (B)(6) 2012. DATE OF EVENT: THE SPECIFIC DATE WAS NOT PROVIDED. THE PATIENT STATED ON (B)(6) 2021 THE SURGERIES HAD ALREADY OCCURRED. OTHER : THE V.A.C.® GRANUFOAM¿ DRESSING IDENTIFIER WAS NOT PROVIDED AND THE PRODUCT WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. BASED ON INFORMATION PROVIDED ON (B)(6) 2021, IT WAS DETERMINED THE ALLEGED INFECTION AND SUBSEQUENT SURGERIES WERE UNRELATED TO ACTIV.A.C.¿ THERAPY SYSTEM. THEREFORE, THE EVENT WAS DEEMED NOT REPORTABLE. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021, IT COULD NOT BE DETERMINED IF THE ALLEGED INFECTION AND SUBSEQUENT SURGERIES WERE RELATED TO THE V.A.C.® GRANUFOAM¿ DRESSING. THE NURSE REPORTED THE WOUND WAS NOT PACKED AGGRESSIVELY OR DEEP ENOUGH WITHIN THE PATIENT'S WOUND BED TO EVACUATE DRAINAGE AND THIS ALLEGEDLY CONTRIBUTED TO THE WOUND INFECTION. THIS IS EVENT IS BEING REPORTED AS A POTENTIAL USE ERROR BASED ON THE CLARIFICATION RECEIVED ON (B)(6) 2021. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WARNING NEVER LEAVE A V.A.C.® DRESSING IN PLACE WITHOUT ACTIVE V.A.C.® THERAPY FOR MORE THAN TWO HOURS. IF THERAPY IS OFF FOR MORE THAN TWO HOURS, REMOVE THE OLD DRESSING AND IRRIGATE THE WOUND. EITHER APPLY A NEW V.A.C.® DRESSING FROM AN UNOPENED STERILE PACKAGE AND RESTART V.A.C.® THERAPY; OR APPLY AN ALTERNATE DRESSING, SUCH AS A WET TO MOIST GAUZE, AS APPROVED DURING TIMES OF EXTREME NEED, BY TREATING PHYSICIAN. FOAM PLACEMENT: ALWAYS USE V.A.C.® DRESSINGS FROM STERILE PACKAGES THAT HAVE NOT BEEN OPENED OR DAMAGED. DO NOT PLACE ANY FOAM DRESSING INTO BLIND / UNEXPLORED TUNNELS. THE V.A.C.® WHITEFOAM¿ DRESSING MAY BE MORE APPROPRIATE FOR USE WITH EXPLORED TUNNELS. DO NOT FORCE FOAM DRESSINGS INTO ANY AREA OF THE WOUND, AS THIS MAY DAMAGE TISSUE, ALTER THE DELIVERY OF NEGATIVE PRESSURE OR HINDER EXUDATE AND FOAM REMOVAL. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM USED IN THE WOUND. DOCUMENT THE FOAM QUANTITY AND DRESSING CHANGE DATE ON THE DRAPE OR FOAM QUANTITY LABEL IF AVAILABLE, AND IN THE PATIENT'S CHART.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE WOUND ALLEGEDLY BECAME SO DEEP THAT THE PATIENT DEVELOPED AN INFECTION AND UNDERWENT TWO SURGERIES. THE HOME HEALTH NURSE REPORTEDLY APPLIED THE INCORRECT FOAM. THE V.A.C.® GRANUFOAM¿ DRESSING WAS APPLIED INSTEAD OF V.A.C. WHITEFOAM¿ DRESSING. ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE PRACTITIONER: THE PHYSICIAN CONFIRMED THE REPORTED INFECTION AND SUBSEQUENT SURGERIES WERE UNRELATED TO THE ACTIV.A.C.¿ THERAPY SYSTEM. THE INFECTION WAS ALLEGEDLY DUE TO INCORRECT PLACEMENT OF THE DRESSING. ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE PRACTITIONER: THE INFECTION WAS ALLEGEDLY DUE TO THE METHOD USED BY THE NURSES WHEN PACKING THE WOUND. THE PATIENT'S WOUND WAS NOT PACKED AGGRESSIVELY OR DEEP ENOUGH WITHIN THE WOUND TO EVACUATE DRAINAGE. NO ADDITIONAL INFORMATION AVAILABLE. ON (B)(6) -2021, KCI QUALITY ENGINEERING COMPLETED AN EVALUATION OF THE ACTIV.A.C.¿ THERAPY UNIT. ON (B)(6) 2021, THE DEVICE PASSED QUALITY CONTROL PROCEDURES AND MET SPECIFICATIONS AT THE KCI SERVICE CENTER BEFORE PLACEMENT WITH THE PATIENT. ON (B)(6)2021, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6)2021, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURES IN KCI QUALITY ENGINEERING, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT. THE V.A.C.® GRANUFOAM¿ DRESSING IDENTIFIER WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE HISTORY REVIEW AND A DEVICE EVALUATION COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839755 V.A.C. GRANUFOAM DRESSING OMP OMP KINETIC CONCEPTS, INC VACDSP ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R