BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK

    MDR report key: 5221701 · Received November 13, 2015

    Report

    Report Number
    2110898-2015-00049
    Event Type
    Injury
    Date Received
    November 13, 2015
    Date of Event
    October 15, 2015
    Report Date
    December 9, 2015
    Manufacturer
    3M HEALTH CARE
    Product Code
    MSH
    PMA / PMN Number
    K121069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT AVAILABLE AT TIME OF INITIAL REPORT. THE SAMPLES RECEIVED WERE VISUALLY REVIEWED AND NO VISUAL NON-CONFORMITIES WERE OBSERVED IN THE RESPIRATOR SAMPLES. THE LOT RECORDS FOR LOT A14300501 WERE REQUESTED FROM THE MANUFACTURING FACILITY. THESE RECORDS WERE REVIEWED AND ALL THE CORRECT COMPONENTS WERE USED AND ALL TESTING WAS COMPLETED AND WITHIN SPECIFICATION FOR THIS LOT. IN ADDITION, THE PROCESSING AIDS THAT COULD CONTACT THE RESPIRATORS DURING MANUFACTURE WERE REVIEWED AND HAD NOT CHANGED IN THE 5 MONTHS BEFORE THE AFFECTED PRODUCT WAS MANUFACTURED AND THE CLEANING PROCEDURES FOR THE MANUFACTURING EQUIPMENT HAD NOT CHANGED IN OVER A YEAR. THERE ARE 3 COMPLAINTS FOR THE APPLICABLE CATALOG NUMBER IN THE PAST TWO YEARS, INCLUDING THIS COMPLAINT. THE THREE COMPLAINTS ARE FOR THREE SEPARATE EVENTS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED SINCE THE PRODUCT WAS LAUNCH IN 2013.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED AFTER ATTEMPTING TO OBTAIN MORE INFORMATION. IT WAS NOTED THAT THE DEVICE WILL BE RETURNED BUT AS OF THE DATE OF THIS REPORT SUBMISSION THE DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION. THE NURSE HAD UNSPECIFIED ACID REFLUX ISSUES ONGOING AT THE TIME IN OCTOBER. SHE ALLEGED SEVERE BURNING AND SORENESS IN THE THROAT ALMOST IMMEDIATELY AFTER DONNING THE MASK. SHE ALLEGED SHORTNESS OF BREATH. THE NURSE USED HER ASTHMA INHALER AND WAS ADMITTED TO THE HOSPITAL WHERE SHE WAS GIVEN UNSPECIFIED BREATHING TREATMENTS. THE NURSE ALLEGED THE SORE THROAT PERSISTED FOR SEVERAL DAYS. AS BEFORE, THE NURSE STATED THAT SHE HAD ACID REFLUX ISSUES ONGOING AT THE TIME OF THE SORE THROAT.

    Description of Event or Problem · 1

    A FEMALE NURSE IN THE HOSPITAL INTENSIVE CARE UNIT ALLEGED A SORE THROAT AND DIFFICULT BREATHING WITHIN 24 HOURS OF DONNING A MODEL 1805 V-FLEX(TM) PARTICULATE RESPIRATOR AND SURGICAL MASK. THE NURSE WAS ADMITTED TO THE HOSPITAL FOR UNSPECIFIED MEDICAL TREATMENT. THE NURSE HAS A HISTORY OF ASTHMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751797 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK RESPIRATOR SURGICAL MASK MSH 3M HEALTH CARE N/A A14300501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other