BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENASYS AB DRSG KIT W SOFTPORT

    MDR report key: 2579099 · Received May 17, 2012

    Report

    Report Number
    3006760724-2012-00004
    Event Type
    Injury
    Date Received
    May 17, 2012
    Date of Event
    April 18, 2012
    Report Date
    May 17, 2012
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K100787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES OR PICTURES WERE RECEIVED FOR EVALUATION HOWEVER, THE KIT LOT NUMBER WAS PROVIDED. THE INVESTIGATION FROM THE KIT MANUFACTURER REVEALED NO SIMILAR PREVIOUS COMPLAINTS REPORTED FOR THIS TYPE OF ISSUE AND A REVIEW OF THE DEVICE HISTORY RECORDS AND QUALITY ASSURANCE RECORDS REVEALED NO NON-CONFORMANCES REPORTED FOR THIS LOT NUMBER DURING THE MANUFACTURING PROCESS. THE WOUND CONTACT LAYER OR ORGAN PROTECTION LAYER (OPL) IS A TRANSLUCENT, EXTENSIBLE WATERPROOF FILM, MADE OF MEDICAL GRADE POLYURETHANE. THE OPL TESTING SPECIFICATIONS INCLUDE STRUCTURAL INTEGRITY VERIFIED TO MEET MINIMUM TENSILE STRENGTH OF 300 GF/CM AND ELONGATION AT BREAK TO EXCEED 40%. THESE ATTRIBUTES PROVIDE FOR A FLEXIBLE MATERIAL DESIGNED TO BE EASY TO APPLY DURING WOUND PREPARATION. AS PER IFU APPLICATION INSTRUCTIONS, EITHER SIDE OF THE OPL MAY BE APPLIED TO EXPOSED ORGANS. THE OPL IS INTENDED TO BE POSITIONED EVENLY INTO THE ABDOMINAL CAVITY, DISTRIBUTING THE SIDES INTO BOTH OF THE LATERAL PARACOLIC GUTTERS. ANY EXCESS MATERIAL ON THE SIDES OF THE OPL MAY BE FOLDED BACK ONTO ITSELF. THE OPL DOES NOT COME IN CONTACT WITH THE SKIN AS IT IS PLACED BETWEEN THE EXPOSED ORGANS IN THE ABDOMINAL CAVITY AND THE FOAM DRESSING. IN ADDITION, OUR MEDICAL ADVISOR REVIEWED THE DETAILS OF THIS EVENT AND CONCLUDED THE FOLLOWING: FISTULAS CAN DEVELOP FOR A VARIETY OF REASONS AND UNLESS NPWT IS IN DIRECT CONTACT WITH THE BOWEL, THERE WOULD BE NO REASON TO IMPLICATE THE DRESSING. THE USUAL CAUSE FOR A FISTULA IS BOWEL DISEASE OR INJURY WHICH CAUSES A LEAK WHICH THEN WORKS ITS WAY OUT THROUGH THE SKIN OR WOUND. SINCE THE CONCEPT OF NPWT IS DIRECTED AT SUBCUTANEOUS LAYERS, I CANNOT SEE HOW DEBRIDEMENT OF SKIN CAN OCCUR WITH A PROPERLY APPLIED DRESSING. NO ADDITIONAL INCIDENTS HAVE BEEN NOTED FOR THIS PRODUCT FOR THIS TYPE OF COMPLAINT. THE COMPLAINT IS RECORDED AND ANY SIMILAR ISSUES WILL BE MONITORED THROUGH THE COMPLAINT SYSTEM. THIS COMPLAINT WILL BE REOPENED AND INVESTIGATED IF MORE INFORMATION IS RECEIVED AT A LATER DATE. WITHOUT ADDITIONAL INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS, RESULTS OF INVESTIGATION TO BE PROVIDED IN SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    WOUND CONTACT LAYER CAUSED A SKIN DEBRIDEMENT AND A FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENASYS AB DRSG KIT W SOFTPORT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800980 2011101978

    Patients

    Seq Age Sex Outcome Treatment
    1 Other