BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEDURE MASK WITH SO SOFT* EARLOOPS, YELLOW

    MDR report key: 10024154 · Received May 5, 2020

    Report

    Report Number
    9616096-2020-00003
    Event Type
    Injury
    Date Received
    May 5, 2020
    Report Date
    June 19, 2020
    Manufacturer
    OWENS & MINOR HALYARD
    Product Code
    FXX
    UDI-DI
    30680651471179
    PMA / PMN Number
    K823078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED THREE (3) UNUSED REPRESENTATIVE SAMPLES WITH NO PRODUCT PACKAGING. THE SAMPLES WERE EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE SAMPLES WERE FOUND TO BE ASSEMBLED ACCORDING TO THE SPECIFICATION DRAWING. ALL THREE (3) SAMPLES WERE INSPECTED ON THE OUTSIDE AND THE INSIDE. THERE ARE NO SHARP EDGES, NO PROTRUDING FIBERS OR FOREIGN MATERIALS OBSERVED. ONE MASK EXHIBITS WHAT APPEARS AS TWO BOND POINTS WHERE THERE MAY BE HOLES. ONE APPARENT HOLE IS OBSERVED FROM THE OUTSIDE OF THE MASK AT THE TOP OF THE MASK AND THE OTHER APPARENT HOLE IS OBSERVED AT THE BOTTOM OF THE MASK IN THE AREA OF ULTRASONIC BONDING. THE AREAS WERE VIEWED UNDER MAGNIFICATION. THE HOLES AT BOTH BOND POINTS IS CONFIRMED. THE LAYER OF MATERIAL IS MISSING INSIDE THE BOND POINTS. WE ARE UNABLE TO CONFIRM THE COMPLAINT OF ALLERGIC REACTION WITH THE EVALUATION PERFORMED IN THE LAB. THE DEVICE HISTORY RECORDS (DHR) EVALUATION WAS PERFORMED FOR THE PRODUCT CODE 104711765 AND LOT NUMBER AM0073101 THAT WAS IDENTIFIED IN THIS COMPLAINT. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURING ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS AND THEN RELEASED BY QUALITY ASSURANCE. A QUALITY NONCONFORMANCE WAS NOT REPORTED AT THE TIME OF PRODUCTION. ALL INFORMATION REASONABLY KNOWN AS OF 30JUN2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. O&M HALYARD, INC. 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTEDLY AVAILABLE FOR THIS COMPLAINT BUT WAS NOT RETURNED WHEN THIS REPORT WAS FILED. ALL INFORMATION REASONABLY KNOWN AS OF 04MAY2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO O&M HALYARD, INC. O&M HALYARD, INC. 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9616096-2020-00001 FOR THE FIRST PATIENT. REFER TO 9616096-2020-00002 FOR THE SECOND PATIENT. IT WAS REPORTED THAT STAFF MEMBERS HAD A REACTION AND REPORTED RESPIRATORY DISTRESS TO EMPLOYEE HEALTH DURING USE WEARING AN (UNKNOWN PRODUCT NUMBER) YELLOW PROCEDURE MASK. ADDITIONAL INFORMATION WAS RECEIVED ON 23-APRIL-2020 THAT STATES THE PRODUCT CODE IDENTIFIED WAS 47117 AND LOT NUMBER LOT: AM0073101. IT WAS REPORTED THAT 3 HAVE EMPLOYEES REPORTED TO EMPLOYEE HEALTH FOR ITCHING, BURNING, TO RASHES, DIFFICULTY BREATHING, AND AN EMPLOYEE USED BENADRYL. THE EMPLOYEES CHANGED THE MASK TO AFTER HAVING A REACTION. ADDITIONAL INFORMATION WAS RECEIVED ON 24-APRIL-2020 THAT STATES (2) FACILITIES LISTED FOR THIS COMPLAINT (B)(6) MEDICAL CENTER, DIFFERENT ADDRESSES, SAME ALERT DATE AND STOCK CODES. ADDITIONAL INFORMATION WAS RECEIVED ON 28-APRIL-2020 THAT STATES THE DURATION OF USE WEARING THE MASK WAS BETWEEN 5 MINUTES TO 8-12 HOURS. THERE WAS NO MEDICAL INTERVENTION PROVIDED AND THE ISSUE WAS RESOLVED AND STOPPED "WHEN THE MASK WAS NOT WORN, OR THE TYPE/BRANDS WERE CHANGED." NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488308 PROCEDURE MASK WITH SO SOFT* EARLOOPS, YELLOW ICP FACIAL PROTECTION PRODUCTS FXX OWENS & MINOR HALYARD 47117 AM0073101 30680651471179

    Patients

    Seq Age Sex Outcome Treatment
    1 Other