BEUDAMED
    FDA Adverse Event Death Summary report: N

    SKIN-PREP WIPES BOX

    MDR report key: 2983584 · Received February 28, 2013

    Report

    Report Number
    3006760724-2013-00002
    Event Type
    Death
    Date Received
    February 28, 2013
    Date of Event
    February 9, 2011
    Report Date
    February 28, 2013
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    NEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES HAVE NOT BEEN RETURNED TO SMITH & NEPHEW FOR EVALUATION. INVESTIGATION INTO RETAIN BATCH RECORDS SHOW THAT INDEPENDENT MICROBIOLOGICAL TESTS WERE CONDUCTED ON THE RETAINS FOR THE LOT REPORTED. THERE WAS NO EVIDENCE OF MICROBIOLOGICAL CONTAMINATION FOUND IN THE RETAIN SAMPLES. AN ACTIVE INVESTIGATION IS CURRENTLY IN PROGRESS AND THE RESULTS OF OUR INVESTIGATION WILL BE DETAILED IN A SUPPLEMENT REPORT.

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW HAS COMPLETED THEIR INVESTIGATION INTO THE REPORTED INCIDENT. AFTER A THOROUGH INVESTIGATION WE WERE UNABLE TO CONFIRM ANY CAUSAL RELATIONSHIP, OR DEVICE FAILURE AS HAVING CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. AN INDEPENDENT MEDICAL REVIEW OF SIMILAR COMPLAINTS CONFIRMED THAT SKIN PREP WIPES IS NOT THE ROOT CAUSE OF THE ISSUE. THERE WAS NO PRODUCT WAS RETURNED BY THE CUSTOMER SO NO TESTING COULD BE PERFORMED ON CUSTOMER SAMPLES. HOWEVER, THE RETAIN SAMPLES OF THIS LOT WERE ANALYZED BY AN INDEPENDENT ANALYTICAL LAB AND NO MICROBIAL CONTAMINATION OR GROWTH WAS NOTED. SKIN PREP WIPES IS AN ISOPROPYL ALCOHOL BASED LIQUID FILM-FORMING SKIN PREPARATION THAT, UPON APPLICATION TO INTACT SKIN, FORMS A PROTECTIVE FILM TO HELP REDUCE FRICTION DURING REMOVAL OF TAPES AND FILMS. PER THE PRODUCT LABELING, IT IS VERY IMPORTANT TO ALLOW TO DRY THOROUGHLY BEFORE ANY DEVICE IS APPLIED. WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE FOR THIS ISSUE. GIVEN THAT PRODUCT HAS SUFFICIENT WARNINGS AND THAT IT HAS BEEN RELOCATED, NO FURTHER INVESTIGATION, OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    SKIN PREP WIPES THOUGHT TO BE CONTAMINATED WITH BACILLUS CEREUS. AFTER USING THE WIPES, THE PATIENT EXPERIENCED A BACTERIAL INFECTION WHICH RESULTED IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86334 SKIN-PREP WIPES BOX BANDAGE, LIQUID, SKIN PROTECTANT NEC SMITH & NEPHEW WOUND MANAGEMENT 420400 0L165

    Patients

    Seq Age Sex Outcome Treatment
    1 Death