BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA SENSITIVE EARLOOP MASK

    MDR report key: 15219015 · Received August 12, 2022

    Report

    Report Number
    1319130-2022-00003
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Report Date
    August 12, 2022
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    FXX
    UDI-DI
    20612479229383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CROSSTEX HAS CONTACTED THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, TO DATE WE HAVE NOT RECEIVED ADDITIONAL INFORMATION. CROSSTEX REQUESTED THAT THE MASKS SUBJECT OF THE EVENT BE RETURNED FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE EVALUATION OF THE RETURNED MASKS CONCLUDED THAT NO FURTHER ACTION WAS NEEDED. MASKS WERE FOUND TO BE WITHIN SPECIFICATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT EMPLOYEES OBTAINED SCRATCHES ON THEIR FACES WHILE WEARING ULTRA SENSITIVE EARLOOP FACE MASKS. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2905936 ULTRA SENSITIVE EARLOOP MASK SURGICAL MASK FXX SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. 73-GCFCXSSF 20612479229383

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown