BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITE ONE SURGICAL MASK BLUE, 50

    MDR report key: 8311908 · Received February 6, 2019

    Report

    Report Number
    9616096-2019-00001
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 25, 2019
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXX
    UDI-DI
    30680651288029
    PMA / PMN Number
    D321003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 06MARCH2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. 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 O&M HALYARD, INC. 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 THAT FOLLOWING THE USE OF A MASK, A DOCTOR HAD AN ALLERGIC REACTION. THE DOCTOR DEVELOPED SWOLLEN LIPS AND TONGUE AND NEEDED TREATMENT, WHICH INCLUDED STERIOD INJECTION. THE DOCTOR WAS INFORMED HIS SYMPTOMS WERE DUE TO AN ALLERGIC RESPONSE. ADDITIONAL INFORMATION WAS RECEIVED ON 15-JAN-2019 FROM THE DOCTOR THAT STATED, ALL OK. NO ADDITIONAL INFORMATION WAS PROVIDED. AS OF 06MARCH2019 NO ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 06FEB2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE USE OF A MASK, A DOCTOR HAD AN ALLERGIC REACTION. THE DOCTOR DEVELOPED SWOLLEN LIPS AND TONGUE AND NEEDED TREATMENT, WHICH INCLUDED STEROID INJECTION. THE DOCTOR WAS INFORMED HIS SYMPTOMS WERE DUE TO AN ALLERGIC RESPONSE. ADDITIONAL INFORMATION WAS RECEIVED ON 15-JAN-2019 FROM THE DOCTOR THAT STATED, ALL OK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103986 LITE ONE SURGICAL MASK BLUE, 50 ICP FACIAL PROTECTION PRODUCTS FXX O&M HALYARD, INC. 28802 UNKNOWN 30680651288029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other