BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLATOR PLUS N95 SURGICAL RESPIRATOR

    MDR report key: 16563966 · Received March 17, 2023

    Report

    Report Number
    1319130-2023-00001
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Report Date
    March 17, 2023
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    MSH
    UDI-DI
    10732224000524
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CROSSTEX HAS CONTACTED THE CUSTOMER REQUESTING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS AND THE STATUS OF THE STUDENTS. TO DATE, WE HAVE NOT RECEIVED ADDITIONAL INFORMATION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THE LOT NUMBERS SUBJECT OF THE REPORTED EVENTS. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY RETURNED THE ISOLATOR PLUS N95 SURGICAL RESPIRATORS FOR EVALUATION. HOWEVER, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT STUDENTS OBTAINED CUTS ON THEIR NOSES WHILE WEARING ISOLATOR PLUS N95 SURGICAL RESPIRATORS. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936759 ISOLATOR PLUS N95 SURGICAL RESPIRATOR SURGICAL RESPIRATOR MSH SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. GPRN95 2035081, 2103481 10732224000524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown