BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISOLVE WIPES

    MDR report key: 2220772 · Received August 23, 2011

    Report

    Report Number
    3006760724-2011-00031
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    KOX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW WAS CONTACTED REGARDING THE ABOVE DESCRIBED INCIDENT, WHICH WAS REPORTED AS A FIELD COMPLAINT FOR "SKIN IRRITATION/REACTION". THE CUSTOMER SENT IN SOME PRODUCT SAMPLES. WE WERE UNABLE TO CONFIRM THE COMPLAINT BASED ON INSPECTION OF THE RETURNED SAMPLES, HENCE LABORATORY TESTING WAS PERFORMED. ALL OF THE RETURNED SAMPLE(S) OF LOTS 0F195, 0F239, 0K207, 0K233, 0M151 AS WELL AS CONTROL SAMPLES (FROM STOCK) OF ADDITIONAL LOTS OF UNI-SOLVE WIPES WERE ANALYZED BY AN INDEPENDENT TEST LABORATORY AND MET FINISHED PRODUCT SPECIFICATIONS WITH NO EVIDENCE OF MICROBIAL CONTAMINATION FOUND. BATCH RECORDS FOR THE LOTS INDICATE ALL SPECIFICATIONS WERE MET AT THE TIME OF RELEASE AND NO INCONSISTENCIES WERE NOTED. AN INDEPENDENT MEDICAL REVIEW CONCLUDED THERE WAS NO CORRELATION BETWEEN THE REPORTED SYMPTOMS AND THE USE OF UNI-SOLVE WIPES.

    Description of Event or Problem · 1

    THIS UNISOLVE COMPLAINT WAS RECEIVED POST SMITH & NEPHEW'S REMEDIAL ACTION (VOLUNTARY RECALL) TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH (REF. RECALL #3006760724-04-06-2011-001R). ADVERSE INCIDENT PATIENT DEVELOPED A RASH AROUND THE STOMA AREA. PATIENT ORIGINALLY THOUGHT HIS RASH WAS CAUSED FROM GLUE ON A TAPE HE USES. PATIENT WIFE STATED HER HUSBAND HAD A BREAKDOWN OF HIS SKIN AFTER SURGERY (B)(6) 2006. PATIENT STARTED USING UNI-SOLVE ADHESIVE REMOVE WIPES AFTER HIS SURGERY DATED (B)(6) 2006. PATIENT WAS TAKEN TO THE EMERGENCY ROOM SEVERAL TIMES IN DUE TO RASH ON AROUND STOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNISOLVE WIPES SOLVENT, ADHESIVE TAPE KOX SMITH & NEPHEW WOUND MANAGEMENT 402300 0F195

    Patients

    Seq Age Sex Outcome Treatment
    1 Other