BEUDAMED
    FDA Adverse Event Other Summary report: N

    SALTER LABS FACE MASK

    MDR report key: 3282819 · Received August 2, 2013

    Report

    Report Number
    2921601-2013-00006
    Event Type
    Other
    Date Received
    August 2, 2013
    Date of Event
    May 8, 2013
    Report Date
    August 3, 2013
    Manufacturer
    SALTER LABS
    Product Code
    BYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 PT, (B)(6), CONTACTED SALTER LABS TO INFORM OF AN EVENT THAT TOOK PLACE ON (B)(6) 2013 WHERE THE PT REPORTED SKIN BLISTERING WHERE THE MASK WAS IN CONTACT WITH HIS SKIN. THE PT VISITED THE ER AND RECEIVED SILVER SULFADIAZINE TO APPLY TOPICALLY. THE PT STATED HE HAD USED OTHER SALTER LABS FACE MASKS SINCE THE INCIDENT WITHOUT ISSUE. ADDITIONAL INFO SALTER LABS WAS ABLE TO GATHER FROM THE PT INCLUDES: THE EQUIPMENT SET UP THE PT WAS USING WAS: OXYGEN CONCENTRATOR (NOT SALTER LABS) CONNECTED TO TUBING (MFR UNK), FIRE BREAK, AND FACE MASK. THE PT'S HOME CARE PROVIDER HAD COME OUT TO SERVICE THE CONCENTRATOR AND REPLACE TUBING, MASK, ETC. THE DAY THE EVENT OCCURRED. AFTERWARDS, THE PT GAVE HIMSELF 20 MINUTES OF OXYGEN TREATMENT AND NOTICED A STINGING SENSATION AND SKIN BLISTERING. HE THEN WENT TO THE ER. HE HAS NOT USED THE CONCENTRATOR WITH TUBING, MASK, ETC. SINCE THE INCIDENT, BUT DID REPORT USING OTHER SALTER LABS FACE MASKS (WITH O2 TANK RATHER THAN CONCENTRATOR) SINCE THE INCIDENT WITHOUT ISSUE. WHILE THE PT WAS INITIALLY RELUCTANT TO RETURN THE DEVICE FOR ANALYSIS, ON (B)(4) 2013, A SALTER LABS REP WAS ABLE TO RETRIEVE THE UNIT FROM THE PT. THE UNIT WILL BE ANALYZED UPON RECEIPT. THIS IS AN INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364041 SALTER LABS FACE MASK FACE MASK BYG SALTER LABS 8150 082310

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization