BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISOLVE WIPES

    MDR report key: 2222477 · Received August 25, 2011

    Report

    Report Number
    3006760724-2011-00033
    Event Type
    Injury
    Date Received
    August 25, 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 INFECTION-GENERAL/SYSTEMIC. THE CUSTOMER SENT IN SOME PRODUCT SAMPLES OF LOT 0F239, BUT NO SAMPLES WERE RETURNED OF LOT 0F197. WE WERE UNABLE TO CONFIRM THE COMPLAINT BASED ON INSPECTION OF THE RETURNED SAMPLES, HENCE LABORATORY TESTING WAS PERFORMED. BOTH THE RETURNED SAMPLE(S) OF LOT 0F239 AND CONTROL SAMPLES OF ADDITIONAL LOTS (FROM STOCK) 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 WAS ALSO CONDUCTED WHICH CONCLUDED THAT THERE IS NO MEDICAL EVIDENCE TO SUPPORT ANY RELATIONSHIP BETWEEN THE USE OF UNISLOVE AND THIS PATIENT'S SYMPTOMS. (B)(4)

    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 A BACTERIAL INFECTION OCCURRED IN THE URINARY TRACK OF THE PATIENT. INTENSE AMOUNT OF PAIN THROUGHOUT HER BACK AND ON THE LOWER PART OF HER STOMACH. VOMITING. WAS SENT TO THE HOSPITAL ON (B)(6)-2011, SPECIFICALLY THE ER, AND WAS FOUND TO BE DEHYDRATED FROM VOMITING. FIRST OCCURRENCE OF THIS SORT TO HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNISOLVE WIPES SOLVENT, ADHESIVE TAPE KOX SMITH & NEPHEW WOUND MANAGEMENT 402300 0F197

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization