BEUDAMED
    FDA Adverse Event Death Summary report: N

    SKIN PREP NON STING WIPES

    MDR report key: 2501657 · Received March 23, 2012

    Report

    Report Number
    3006760724-2012-00001
    Event Type
    Death
    Date Received
    March 23, 2012
    Date of Event
    February 25, 2011
    Report Date
    March 22, 2012
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    KMF
    PMA / PMN Number
    K973228
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS, ANTICIPATING MEDICAL RECORDS AND SAMPLE RETURNS FROM CUSTOMER. RESULTS OF INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENT REPORT.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED BY THE CUSTOMER. CONTROL SAMPLES (FROM STOCK) OF NO-STING SKIN PREP WIPES WERE ANALYZED BY AN INDEPENDENT TEST LABORATORY AND MET FINISHED PRODUCT SPECIFICATIONS WITH NO EVIDENCE OF MICROBIAL CONTAMINATION FOUND. THE SUPPLIER INVESTIGATION COULD NOT BE PERFORMED SINCE SUPPLIER IS NO LONGER MANUFACTURING. THIS REPORT WAS ALSO FORWARDED TO OUR MEDICAL ADVISOR WHO REPORTED THE FOLLOWING: THE PATIENT'S WIFE RECEIVED THE INFORMATION ABOUT THE WIPES RECALL AFTER HER HUSBAND'S DEATH, AND ALTHOUGH SHE HAS EXPRESSED THE OPINION THAT THE WIPES WERE, IN PART, RESPONSIBLE, SHE HAS NOT FORWARDED PERTINENT MEDICAL RECORDS OR THE REMAINING WIPES IN HER POSSESSION SO THAT A THOROUGH INVESTIGATION COULD BE CONDUCTED. THE CAUSE OF DEATH IS NOT AVAILABLE TO US, AND THERE IS NOTHING IN THE REPORTS TO SUGGEST THAT THERE WAS ANY RELATIONSHIP BETWEEN THE PRESSURE ULCER, ITS TREATMENT OR INFECTION AND HIS DEATH. THERE IS NO INFORMATION REGARDING THIS COMPLAINT TO SUGGEST THAT THE WIPES WERE RELATED IN ANY WAY TO THIS PATIENT'S DEATH.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE CONTACTED SMITH & NEPHEW ON (B)(6) 2012 TO INFORM US THAT HER HUSBAND HAD PASSED AWAY ON (B)(6) 2011. CUSTOMER'S WIFE STATED THAT NO STING SKIN-PREP WIPES WERE ONE OF THE PRODUCTS BEING USED AT THE TIME OF HER HUSBAND'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKIN PREP NON STING WIPES BANDAGE, LIQUID KMF SMITH & NEPHEW WOUND MANAGEMENT 59420600 9L169

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death