BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISOLVE WIPES

    MDR report key: 2251027 · Received September 16, 2011

    Report

    Report Number
    3006760724-2011-00044
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THESE LOTS WERE REVIEWED AND CONFIRMED THAT PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO THE SPECIFICATIONS. LOT 0050 WAS MANUFACTURED BY (B)(4) AND RELEASED IN APRIL/ MAY 2011 AND LOT 523633 WAS MANUFACTURED AND RELEASED IN JULY 2009. (B)(4). THERE WERE NO CHANGES MADE TO THE MANUFACTURING PROCESS OR INGREDIENTS. ADDITIONALLY MICROBIAL LIMIT TESTING WAS PERFORMED ON THIS LOT 0050 PRIOR TO RELEASE AND CONFIRMED THAT PRODUCT WAS NEGATIVE FOR E-COLI. THE PRODUCT IS COMPRISED OF ORGANIC SOLVENTS AND IS NOT CONDUCIVE TO MICROBIAL ACTIVITY. 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. SOME OTHER ADVERSE EVENT COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT CODE. THERE IS NOT ENOUGH INFORMATION IN THE COMPLAINT TO DETERMINE WHERE THIS PRODUCT WAS USED AND SO (B)(4) ASSESSMENT FOR RISK IS DIFFICULT. (B)(4). MEDICAL AND CLINICAL REVIEWS CONDUCTED FOR SIMILARLY RELATED EVENTS HAVE CONCLUDED THAT THE WIPES PRODUCT IS LIKELY NOT THE ROOT CAUSE OF THE SYMPTOMS REPORTED IN THIS COMPLAINT. GIVEN THAT THIS IS AN ISOLATED INCIDENT WITH THIS LOT CODE AND THIS ISSUE, THERE IS NO OTHER CORRECTIVE ACTION WARRANTED ON THIS COMPLAINT.

    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 EXPERIENCING PAIN IN LUNGS. RECENTLY DISCHARGED FROM HOSPITAL, DIAGNOSED WITH HAVING (B)(6). THREE HOSPITAL VISITS SINCE USING UNI-SOLVE WIPES, FROM (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNISOLVE WIPES SOLVENT, ADHESIVE TAPE KOX SMITH & NEPHEW WOUND MANAGEMENT 402300 0050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization