BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M PROCEDURE MASK

    MDR report key: 3625147 · Received February 4, 2014

    Report

    Report Number
    2110898-2014-00008
    Event Type
    Injury
    Date Received
    February 4, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    3M HEALTH CARE
    Product Code
    FXX
    PMA / PMN Number
    K910182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN UNUSED SAMPLE WAS RECEIVED FROM THE CUSTOMER AND IT APPEARS THAT THE MATERIAL THAT WAS INHALED WAS EXCESS POLYPROPYLENE EDGE WRAP THAT WAS CUT FROM ONE OF THE CORNERS OF THE 1820 MASK BUT HAD MOST LIKELY REMAINED CONTAINED ON THE NONWOVEN AREA OF THE INNER WEB. BATCH RECORDS WERE REVIEWED FOR LOT 2012-1020 BY THE MANUFACTURING FACILITY AND NO DEVIATIONS FROM THE VALIDATED PROCESS WERE FOUND. RETAIN SAMPLES WERE INSPECTED AND NO ISSUES WERE FOUND INCLUDING NO APPARENT EXCESS EDGE WRAP. NO HISTORICAL COMPLAINTS WERE FOUND FOR THIS ISSUE WITH THE 1820 MASK. THE MANUFACTURING FACILITY HAD REVIEWED THE ISSUE AND HAD DETERMINED THAT THE ROOT CAUSE HAD MOST LIKELY COME FROM THE OPERATOR NOT REMOVING THE EXCESS EDGE PROPERLY AS THE CUTTING OF THE EDGE WRAP IS A MANUAL PROCESS. THE ACTUAL DEVICE USED WAS NOT RETURNED BY THE USER. THE USER SENT A REPRESENTATIVE SAMPLE FROM THE SAME LOT AND THERE WAS ONE VERY SMALL LOOSE PIECE OF MATERIAL FOUND ON THE MASK. THERE WAS A NEW OPERATOR PERFORMING THE MANUAL PROCESS. WORK INSTRUCTION FOR CONTROL OF EDGE MACHINE AND CUT EDGE METHOD AND STANDARDS WILL BE REVISED TO PROVIDE MORE DETAIL OF CUTTING AND REMOVAL EXCESS EDGE.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT WHILE DONNING ON 1820 MASK, SHE INHALED TWO PIECES OF FOREIGN MATTERS. SHE IMMEDIATELY COUGHED UP ON PIECE, IT WAS A FABRIC MATERIAL 1 X 1/2 CM SIMILAR TO THE FABRIC USED ON THE EDGE OF MASK. IT HAS THE PERFORATED PATTERN. AT AROUND 4 PM SAME DAY, SHE HAD A BRONCHOSCOPY LAVAGE TO TRY TO REMOVE THE SECOND PIECE. THE PERSON WHO PERFORMED THE PROCEDURE SAID HE COULD NOT SEE ANY FOREIGN OBJECT IN HER LUNG, BUT DID SEE SOME INFLAMMATION IN HER LUNG. THE DOCTOR INDICATED SHE WILL WAIT ONE WEEK TO SEE HOW SHE IS FEELING AND WILL DETERMINE AT THAT TIME IF SHE NEEDS TO SEEK FURTHER MEDICAL CONSULTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73654 3M PROCEDURE MASK MASK, SURGICAL 878.4040 FXX 3M HEALTH CARE NA 2012-10-20

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention