BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEDURE MASK WITH SO SOFT* EARLOOPS, YELLOW

    MDR report key: 7897944 · Received September 21, 2018

    Report

    Report Number
    9616096-2018-00002
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    August 18, 2018
    Report Date
    September 27, 2018
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXX
    UDI-DI
    30680651471179
    PMA / PMN Number
    K823078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS REPORTED TO BE AVAILABLE FOR RETURN. HOWEVER, THE SAMPLE WAS NOT RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 25OCTOBER2018 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 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 O&M HALYARD 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 O&M HALYARD, INC., PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER WHO STATED THAT SHE EXPERIENCED AN ASTHMA ATTACK ON HOUR INTO WEARING THE MASK. THE CUSTOMER STATED THAT SHE EXPERIENCED SHORTNESS OF BREATH, RR 16 BPM, HR 120, SATURATION OF 96%, AND WELTS ON HER FACE. SHE WAS TAKEN TO THE EMERGENCY ROOM AT WORK AND TREATED WITH ALBUTEROL, THEN LEVALBUTEROL. THE CUSTOMER HAS HAD ALLERY TESTING AND IS ALLERGIC TO ALBUTEROL POLYESTER, NUTS, LATEX, GRASS, AND TREES. AFTER THE LEVALBUTEROL TREATMENT THE CUSTOMER'S SUMPTOMS RESOLVED, THE NEXT DAY THE CUSTOMER ALSO TOOK ANOTHER INHALER MDI TREATMENT AND A NECULIZER OF LEVALBUTEROL. THE CUSTOMER STATE THAT SHE TAKES BENADRYL PRN OR AS NEEDED.

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 21SEP2018 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 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 O&M HALYARD COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER WHO STATED THAT SHE EXPERIENCED AN ASTHMA ATTACK ON HOUR INTO WEARING THE MASK. THE CUSTOMER STATED THAT SHE EXPERIENCED SHORTNESS OF BREATH, RR 16 BPM, HR 120, SATURATION OF 96%, AND WELTS ON HER FACE. SHE WAS TAKEN TO THE EMERGENCY ROOM AT WORK AND TREATED WITH ALBUTEROL, THEN LEVALBUTEROL. THE CUSTOMER HAS HAD ALLERGY TESTING AND IS ALLERGIC TO ALBUTEROL POLYESTER, NUTS, LATEX, GRASS, AND TREES. AFTER THE LEVALBUTEROL TREATMENT THE CUSTOMER'S SYMPTOMS RESOLVED, THE NEXT DAY THE CUSTOMER ALSO TOOK ANOTHER INHALER MDI TREATMENT AND A NEBULIZER OF LEVALBUTEROL. THE CUSTOMER STATE THAT SHE TAKES BENADRYL PRN OR AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739399 PROCEDURE MASK WITH SO SOFT* EARLOOPS, YELLOW ICP FACIAL PROTECTION PRODUCTS FXX O&M HALYARD, INC. 47117 UNKNOWN 30680651471179

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other