BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISOLVE WIPES

    MDR report key: 2251035 · Received September 16, 2011

    Report

    Report Number
    3006760724-2011-00045
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    May 26, 2011
    Report Date
    August 31, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    KOX
    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 NAMED INCIDENT, WHICH WAS REPORTED AS A FIELD COMPLAINT FOR "INFECTION-SITE/LOCAL". THE CUSTOMER SENT NO SAMPLES OF UNI-SOLVE WIPES, AND NO LOT NUMBER WAS PROVIDED. WE WERE UNABLE TO CONFIRM THE COMPLAINT BASED ON INSPECTION OF THE RETURNED SAMPLES, HENCE LABORATORY TESTING WAS PERFORMED. CONTROL SAMPLES (FROM STOCK) OF MULTIPLE 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 IS NO MEDICAL EVIDENCE TO SUPPORT ANY RELATIONSHIP BETWEEN THE USE OF UNISOLVE WIPES AND THE PATIENT'S SYMPTOMS.

    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). PATIENT WAS HOSPITALIZED FOR SEVEN DAYS AND IT WAS DETERMINED BY THE INFECTIOUS DISEASE DR. THAT IT WAS HIGHLY LIKELY THAT THE INFECTION (CELLULITES) WAS A RESULT OF THE INSULIN PUMP SITE WHERE PATIENT WAS USING SMITH & NEPHEW PRODUCT TO PREP FOR INFUSION. PATIENT WAS ON ANTIBIOTICS NOT ONLY IN THE HOSPITAL, BUT FOR SEVERAL WEEKS AFTER BEING RELEASED BECAUSE THE INFECTION HAD ENTERED PATIENTS' BLOOD STREAM. THIS EVENT IS ALSO ASSOCIATED WITH (B)(4) WHICH WAS REPORTED AGAINST IV-PREP WIPES (REF. MDR#3006760724-2011-00003).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization