BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICOM SAFEMASK MASTER SERIES L3

    MDR report key: 10730882 · Received October 23, 2020

    Report

    Report Number
    9611959-2020-00004
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    September 22, 2020
    Report Date
    March 10, 2021
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    FXX
    UDI-DI
    10686864047671
    PMA / PMN Number
    K051291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION SHOWS THAT IF THE ROLLS OF RAW MATERIAL ARE LEFT UNCOVERED, THEY CAN COME IN CONTACT WITH DUST. DUST AND DEBRIS COULD CAUSE THE SKIN IRRITATION (RASHES). THE HANDLING OF MATERIAL TO MACHINES BY FORKLIFT DRIVERS WAS CHECKED, THE MATERIAL SPECIFICATION SHEET HAS BEEN VERIFIED AS WELL. IT WAS NOTICED THAT SOME MATERIAL WERE UNCOVERED AND EXPOSED TO DUST AND DEBRIS RETURNED SAMPLES WERE EVALUATED. NO VISUAL DEFECTS WERE OBSERVED. ALSO, THE RETURNED MASKS WERE WORN FOR A PERIOD OF TIME (SINGLE USE NOT FOR LONG TIME OR THE WHOLE DAY), NO SKIN PROBLEM HAPPENED. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE WEARING OF A SINGLE MASK FOR A LONG PERIOD COULD CAUSE THE FIBERS TO BREAK DOWN AND DETACH FROM THE MASK, WHICH CAN CAUSE THE IRRITATION. CORRECTIVE ACTIONS: ON A DAILY BASIS, MATERIAL HANDLERS AND WAREHOUSE PERSONNEL WILL PERFORM CHECKS TO MAKE SURE THAT THE RAW MATERIAL IS ENTIRELY COVERED WITH NO HOLES IN THE WRAPPERS WHEN STORED IN THE WAREHOUSE/STAGING AREAS. ANY MATERIAL WITH HOLES IN THE WRAPPERS WILL BE AUTOMATICALLY DISQUALIFIED FROM USE IN THE PRODUCTION. OPERATORS WILL MAKE SURE THAT THE MATERIAL IS COVERED WHEN OUT ON THE FLOOR, AND MAINTENANCE /WAREHOUSE STAFF WILL START STRETCH WRAPPING USED ROLLS BEFORE TAKING THEM BACK TO THE WAREHOUSE.

    Description of Event or Problem · 0

    THE FOLLOWING INCIDENT WAS REPORTED TO AMD MEDICOM ON 24-SEP-2020 FOR MEDICOM SAFEMASK MASTER SERIES L3 ITEM 2085: "DURING GENERAL DENTAL DUTIES ROUGHLY 6 STAFF MEMBERS WERE ALL EXPERIENCING SOME TYPE OF REACTION FROM THESE MASKS. MOST EXPERIENCED A RASH ON THEIR FACE ON THE BOTTOM PART OF THEIR CHIN AS WELL AS NEAR THEIR MOUTH WHILE ONE OF THE STAFF MEMBERS AS THEY WERE BREATHING IN FELT THAT THE FIBERS INSIDE THE MASK GAVE HER SHORTNESS OF BREATH, MAKING IT HARD TO BREATHE. SHE WENT TO THE HOSPITAL WHERE SHE WAS GIVEN BENADRYL AND WAS MONITORED. THE SAME DAY SHE WENT BACK TO WORK. ONCE ALL STOPPED WEARING THE RASH HAD CLEARED. NO STAFF SPECIFICS WERE PROVIDED AND AS THEY HAVE ALREADY SENT BACK USING LABEL THAT WAS PROVIDED, THEY COULD NOT PROVIDE THE LOT NUMBER OF THE MASKS. THIS WAS THE FIRST TIME USING THESE TYPES OF MASKS."

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE FOLLOWING INCIDENT WAS REPORTED TO AMD MEDICOM ON SEPTEMBER 24, 2020 FOR MEDICOM SAFEMASK MASTER SERIES L3 ITEM 2085: "DURING GENERAL DENTAL DUTIES ROUGHLY 6 STAFF MEMBERS WERE ALL EXPERIENCING SOME TYPE OF REACTION FROM THESE MASKS. MOST EXPERIENCED A RASH ON THEIR FACE ON THE BOTTOM PART OF THEIR CHIN AS WELL AS NEAR THEIR MOUTH WHILE ONE OF THE STAFF MEMBERS AS THEY WERE BREATHING IN FELT THAT THE FIBERS INSIDE THE MASK GAVE HER SHORTNESS OF BREATH, MAKING IT HARD TO BREATHE. SHE WENT TO THE HOSPITAL WHERE SHE WAS GIVEN BENADRYL AND WAS MONITORED. THE SAME DAY SHE WENT BACK TO WORK. ONCE ALL STOPPED WEARING THE RASH HAD CLEARED. NO STAFF SPECIFICS WERE PROVIDED AND AS THEY HAVE ALREADY SENT BACK USING LABEL THAT WAS PROVIDED, THEY COULD NOT PROVIDE THE LOT NUMBER OF THE MASKS. THIS WAS THE FIRST TIME USING THESE TYPES OF MASKS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188783 MEDICOM SAFEMASK MASTER SERIES L3 MASK FXX AMD MEDICOM INC. 2058 10686864047671

    Patients

    Seq Age Sex Outcome Treatment
    1 Other