BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI-SOLVE WIPES

    MDR report key: 2214876 · Received August 17, 2011

    Report

    Report Number
    3006760724-2011-00016
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 16, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    KOX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENT REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED BY THE CUSTOMER. OTHER RETURN SAMPLES OF THE REPORTED LOTS 0K209 AND 0H229 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 UNSOLVED COMPLAINT THAT 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 HAS BEEN IN AND OUT OF (B)(6) LOCATED IN (B)(4) SINCE (B)(6) 2011. PATIENT DIAGNOSED WITH HAVING DIARRHEA. PATIENT WILL BE GOING TO (B)(6) FOR TESTING TO FIND OUT WHAT'S CAUSING THE REOCCURRENCES OF DIARRHEA. PATIENT SISTER WONDERING IF HER SISTER'S DIARRHEA IS ASSOCIATED WITH SMITH & NEPHEW RECALL WIPES. PATIENT DEVELOPED PNEUMONIA WHILE IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNI-SOLVE WIPES SOLVENT, ADHESIVE TAPE KOX SMITH & NEPHEW WOUND MANAGEMENT 402300 0H229

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization