BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISOLVE WIPES

    MDR report key: 2251033 · Received September 16, 2011

    Report

    Report Number
    3006760724-2011-00043
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    May 23, 2011
    Report Date
    August 31, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    KOX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO SAMPLES RETURNED BY THE CUSTOMER AND SO COMPLAINT CANNOT BE CONFIRMED. THE BATCH RECORDS FOR THIS LOT WAS REVIEWED AND CONFIRMED THAT PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO THE SPECIFICATIONS. (B)(4). THE RETAIN SAMPLES WERE NOT TESTED SINCE HISTORICAL REVIEW OF THE PRODUCT INDICATES THAT ADDITIONAL TESTING IS NOT WARRANTED. THERE WERE NO CHANGES MADE TO THE MANUFACTURING PROCESS OR INGREDIENTS. THE S&N PRODUCTION ENVIRONMENT WAS CONTROLLED AND ADEQUATE TESTING WAS PERFORMED TO ENSURE THAT PRODUCT IS MANUFACTURED UNDER CLEAN ENVIRONMENT FOR SAFE AND EFFICACIOUS PRODUCT. UNI-SOLVE ADHESIVE REMOVER IS FORMULATED TO REDUCE ADHESIVE TRAUMA TO THE SKIN BY THOROUGHLY DISSOLVING DRESSING TAPE AND APPLIANCE ADHESIVES- HYDROCOLLOID-BASED, ACRYLIC-BASED AND RUBBER-BASED ADHESIVES. THE PRODUCT IS COMPRISED OF ORGANIC SOLVENTS AND IS NOT CONDUCIVE TO MICROBIAL ACTIVITY. THE COMPLAINT DOES NOT PROVIDE ANY DETAILS IF THE PRODUCT WAS USED TO CLEAN THE ADHESIVES OR TO REMOVE THE MEDICAL TAPE. BASED ON MEDICAL AND CLINICAL REVIEW OF SIMILAR COMPLAINTS THE WIPES PRODUCT IS LIKELY NOT THE ROOT CAUSE OF THE SYMPTOMS REPORTED IN THIS COMPLAINT. RECENTLY, PRERELEASE MICROBIAL LIMIT TESTING WAS ADDED FOR THIS PRODUCT.

    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). IN ADDITION, THE LOT NUMBER LISTED IN THIS EVENT WAS PRODUCED PRIOR TO THE TRANSFER OF MANUFACTURING; THEREFORE THE LOT NOTED WAS NOT SUBJECT TO THE RECALL. ADVERSE EVENT (B)(6) 2010, (B)(6) WAS ADMITTED TO HOSPITAL BECAUSE OF DIARRHEA AND LEFT SIDE STOMACH HURTS WITH SORES AROUND STOMA; HE STAYED FOR A WEEK. IN (B)(6) HE WAS ADMITTED TO HOSPITAL WITH THE SAME CONDITION, SORES AROUND STOMA. THE HOSPITAL TREATED WITH FLUID AND ANTIBIOTICS. HE THEN RETURNED TO HOSPITAL IN (B)(6) FOR THE 3RD TIME WITH THE SAME CONDITION, DIARRHEA, AND SORES AROUND THE STOMA. THE DR. DECIDED IT WAS A BACTERIA. (B)(6) STAYED IN FOR 3 DAYS. THEY SENT HIM HOME WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNISOLVE WIPES SOLVENT, ADHESIVE TAPE KOX SMITH & NEPHEW WOUND MANAGEMENT 402300 523909

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O