BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVAPLUS BOUFFANT CAP - SPUNBOND, BLUE, LARGE

    MDR report key: 3596204 · Received January 29, 2014

    Report

    Report Number
    1033422-2014-00002
    Event Type
    Injury
    Date Received
    January 29, 2014
    Report Date
    December 30, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    FYF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD DETERMINED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO ESTABLISHED MANUFACTURING PROCEDURES USING THE CORRECT QUALIFIED MATERIALS, INCLUDING THE ELASTIC COMPONENT, AND MET ALL SPECIFICATIONS. THE OPERATORS WHO MANUFACTURED THE REFERENCED PRODUCT LOT DID NOT REPORT ANY REACTION TO THE COMPONENT MATERIALS OR FINAL PRODUCT. ADDITIONALLY, THERE HAVE BEEN NO OTHER REPORTS OF AN UNTOWARD USER REACTION TO THE DEVICE AND LOT REFERENCED IN THIS REPORTED EVENT. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS; THEREFORE, THE DEVICE COULD NOT BE ANALYZED AND ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, ¿TWO PEOPLE AT THE FACILITY, A NURSE AND A PATIENT, HAD SEVERE REACTIONS TO THE ELASTIC ON THE BOUFFANT CAP. THE NURSE BROKE OUT IN A SEVERE REACTION AROUND WHERE THE ELASTIC MADE CONTACT WITH HER SKIN AND THE PATIENT HAD AN ANAPHYLACTIC REACTION. THE NURSE REMOVED THE BOUFFANT AND NO LONGER WEARS IT, SHE WEARS A CLOTH CAP. THE PATIENT EXPERIENCED BLISTERING AROUND THE FACE WHERE THE ELASTIC BAND MADE CONTACT WITH THE SKIN AND CAUSED DIFFICULTY BREATHING. THE BOUFFANT CAP WAS REMOVED AND THE PATIENT WAS GIVEN IV BENADRYL." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63437 NOVAPLUS BOUFFANT CAP - SPUNBOND, BLUE, LARGE FYF KIMBERLY-CLARK HEALTH CARE 0160934001

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR