BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKIN PREP WIPES

    MDR report key: 2220122 · Received August 23, 2011

    Report

    Report Number
    3006760724-2011-00027
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    April 28, 2011
    Report Date
    August 22, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    NEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. 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 LOTS 0G184 AND 0K255 AS WELL AS CONTROL SAMPLES ADDITIONAL LOTS (FROM STOCK) OF SKIN PREP 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 WAS NO CORRELATION BETWEEN THE REPORTED SYMPTOMS AND THE USE OF SKIN PREP WIPES.

    Description of Event or Problem · 1

    THIS SKIN PREP 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 (B)(6) WAS HOSPITALIZED (B)(6) 2011 FOR A U.T.I AND HE WAS GIVEN ANTIBIOTICS INTRAVENOUSLY FOR 5 DAYS AND RELEASED AND PRESCRIBED ANTIBIOTICS TO TAKE TILL THEY WERE GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKIN PREP WIPES BANDAGE, LIQUID, SKIN PROTECTANT NEC SMITH & NEPHEW WOUND MANAGEMENT 420400 0G184

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization