BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENASYS F MEDIUM W/ SOFT PORT

    MDR report key: 2972889 · Received February 21, 2013

    Report

    Report Number
    3006760724-2013-00001
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    October 4, 2012
    Report Date
    February 21, 2013
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K082211
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT INDICATES THAT FOAM WAS USED IN THE TREATMENT OF THE WOUND, AND THAT A PIECE OF FOAM WAS FOUND IN THE WOUND SITE DURING A PROCEDURE PERFORMED AFTER NPWT THERAPY HAD CONCLUDED. AFTER A THOROUGH INVESTIGATION, WE WERE UNABLE TO CONFIRM A DEVICE FAILURE AS HAVING CAUSED, OR CONTRIBUTED TO THE REPORTED EVENT. THE DESCRIPTION OF FOAM FOUND IN WOUND IS A POSSIBILITY FOR GRANULATION AND ADHESION AFTER NEGATIVE PRESSURE WOUND TREATMENT. WHILE GRANULATION IS A DESIRED RESULT FROM EFFECTIVE WOUND TREATMENT, THE ADHESION OF TISSUE TO OPEN CELL FOAM IS LIKELY TO OCCUR, ESPECIALLY IF THE FOAM PARTICLE IS SMALL ENOUGH NOT TO BE READILY DETECTED IN A PREVIOUS PROCEDURE. THE FOAM COULD HAVE REMAINED UNDETECTED FOR A PERIOD OF TIME, THEN FOUND VISUALLY OR TRACED FROM THE PAIN SYMPTOMS DESCRIBED BY THE PATIENT- ALL TYPICAL SIGNS OF HUMAN BODY RESPONSE TO FOREIGN PARTICLE. THE MOST PROBABLE ROOT CAUSES FOR FOAM PRESENT IN A WOUND ARE FOAM TRIMMING PERFORMED DIRECTLY OVER THE WOUND SITE INTRODUCING PARTICLES TO WOUND, FOAM EDGES OF TRIMMED CUT FOAM ATTACHING TO GRANULATION AS FOAM IS REMOVED, UNDERMINING OR TUNNELING HIDING THE FOAM PARTICLE FROM VIEW. AS A METHOD OF INSTRUCTION AND PREVENTION, GUIDELINES FOR PROPER APPLICATION OF FOAM DRESSING ARE INCLUDED TO PREVENT THE END USER FROM DROPPING FOAM DEBRIS INTO THE WOUND DURING THE APPLICATION OF THE FOAM. THERE ARE INSTRUCTIONS FOR DRESSING MONITORING, DRESSING CHANGES, AND DRESSING REMOVAL THAT PREVENT FOAM DEBRIS PROBLEMS. AS PART OF THE INVESTIGATION, THE MANUFACTURING FACILITY REVIEWED THEIR PROCESSES AND PROCEDURES; NO FAILURES OR DISCREPANCIES WERE FOUND. NO FURTHER INVESTIGATION OR CORRECTIVE ACTION WILL BE PERFORMED AT THIS TIME. SMITH & NEPHEW WILL CONTINUE TO MONITOR THE COMPLAINT SYSTEM, AS WELL AS OTHER POST-MARKET SURVEILLANCE ACTIVITIES FOR ANY ADVERSE TRENDS SIMILAR TO THIS EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, OR ANY NEGATIVE TRENDS DEVELOP WE WILL ASSESS THE NEED FOR ADDITIONAL INVESTIGATION OR POTENTIAL CORRECTIVE ACTION.

    Additional Manufacturer Narrative · 1

    USER FACILITY REPORTED EVENT THROUGH MAUDE ON (B)(4) 2012; SMITH & NEPHEW RECEIVED THE REPORT FROM THE FDA, DIVISION OF POSTMARKET SURVEILLANCE IN OUR (B)(4) OFFICE ON (B)(4) 2013. NO DEVICE OR SAMPLE IS EXPECTED TO BE RETURNED FOR EVALUATION. HOWEVER, AN ACTIVE INVESTIGATION IS IN PROGRESS, AND THE RESULTS OF THE INVESTIGATION WILL BE SUBMITTED IN A SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA, NPWT PLACED AND FOAM CHANGED REGULARLY UNTIL DISCHARGE. PATIENT CONTINUED NPWT WITH HOME HEALTH FOLLOW UP. LAST VISIT TO WOUND CLINIC NOTED THAT WOUND WAS HEALED HOWEVER PATIENT RETURNED TO PHYSICIAN'S OFFICE FOR COMPLAINT OF PERIUMBILICAL DRAINAGE AS WELL AS SUPERFICIAL TISSUE CHANGES. ULTRASOUND PERFORMED AND SUB DERMAL FLUID WAS NOTED. PHYSICIAN INCISED WOUND AND VISUALIZED A RETAINED FOREIGN BODY. PATIENT WAS ADMITTED FOR REMOVAL OF FOREIGN BODY IN THE FORM OF RETAINED WOUND VAC SPONGE. PROCEDURE WAS WITHOUT COMPLICATION, PATIENT DISCHARGED IN STABLE CONDITION. FOLLOW UP WITH WOUND CARE CLINIC HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76163 RENASYS F MEDIUM W/ SOFT PORT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800975

    Patients

    Seq Age Sex Outcome Treatment
    1 Other