BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICOM SAFEMASK MASTER SERIES

    MDR report key: 7899992 · Received September 21, 2018

    Report

    Report Number
    9611959-2018-00002
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    June 7, 2018
    Report Date
    September 18, 2018
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    FXX
    UDI-DI
    10686864040252
    PMA / PMN Number
    K051291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 18-SEP-2018, A MEDWATCH WAS REPORTED TO THE FDA BY AMD MEDICOM WHICH REFERS TO MEDICOM MASK PRODUCT ITEM CODES 2050, 2051, 2052 & 2053. THE FOLLOWING EVENT WAS REPORTED: "THE FRAGRANCE ADDED TO THE MASKS CAUSED AN ALLERGIC REACTION. ADVERSE REACTIONS INCLUDED, CONGESTION, RESTRICTED BREATHING, WATERY EYES. ITEMS# 2050 (LOT 1746), 2051 (LOT 1744), 2052 (LOT 1447), 2053 (1728)." CUSTOMER COMPLAINT WAS LOGGED AS PRODUCT QUALITY COMPLAINT (B)(4). SINCE NO RETURN SAMPLES WERE RECEIVED, RETAIN SAMPLES WERE SUBMITTED TO THIRD PARTY LABORATORY FOR TESTING. AN EVALUATION OF THE COMPLAINT WAS PERFORMED BY AMD MEDICOM AND IT WAS DETERMINED THAT ADDITIONAL INFORMATION WAS REQUIRED IN ORDER TO COMPLETE THE INVESTIGATION; THEREFORE, CUSTOMER WAS CONTACTED ON 13 & 14-AUG-2018. THE FOLLOWING INFORMATION WAS RECEIVED: SUMMARY OF THE 1ST COMMUNICATION ON 13-AUG-2018: PATIENT WAS CONTACTED BUT NOT AVAILABLE. THEREFORE, OFFICE MANAGER WHO REPORTED THE INCIDENT PROVIDED ADDITIONAL INFORMATION. OFFICE MANAGER ELABORATED ON THE ADVERSE REACTION AS SUMMARIZED BELOW: THE SURGICAL MASKS IN QUESTION WERE A RE-ORDER PURCHASED ON SALE BY THE CUSTOMER. PREVIOUS LOTS PURCHASED WERE ALL OK AND WERE USED BY MULTIPLE PEOPLE WITH NO REPORTED ADVERSE REACTIONS. THE LOTS IN QUESTION (I.E. FOR ITEM CODES 2050, 2051, 2052 AND 2053) WERE ALL FROM ONE DISTRIBUTOR AND WERE USED BY ONLY ONE PERSON, PATIENT IDENTIFIED AS (B)(6). THE MASKS CAUSED IMMEDIATE REACTIONS UPON USAGE. SYMPTOMS INCLUDED; COMPLETE AND SEVERE SINUS CONGESTION, WHEEZING WITH CONSTRICTION OF THE UPPER BRONCHIAL, EYES BECAME WATERY, ITCHY, PUFFY AND RED. A FEW OTHER MASKS WERE TRIED (LOTS OF ITEM CODES 2050, 2051, 2052 AND 2053) OVER A PERIOD OF 7-10 DAYS WITH CONTINUATION OF SYMPTOMS. THE PATIENT (B)(6) HAS BEEN A CDA SINCE 2007 AND HAS NEVER HAD AN OCCURRENCE OF THIS KIND BEFORE. UPON CESSATION OF THE USAGE OF THE MASKS, ALL SYMPTOMS RECEDED WITHIN TWO (2) TO THREE (3) DAYS. SUMMARY OF THE 2ND CALL 14-AUG-2018 SPOKEN AGAIN WITH OFFICE MANAGER TODAY TO DISCUSS IF PATIENT TOOK MEDICATION TO RELIEVE THE SYMPTOMS, SHE SUFFERED DURING THE 7-10 DAYS THAT SHE WORE THE MASKS. OFFICE MANAGER CONFIRMED THAT THE PATIENT (B)(6) DID NOT TAKE ANY MEDICATION TO RELIEVE THE SYMPTOMS NOR DID SHE SEEK OUTSIDE MEDICAL ATTENTION. SHE SAID THE PATIENT (B)(6) HAD NOTICED A NEW SCENT ON THE MASKS THAT WERE NOT PRESENT ON THE PREVIOUS LOTS PURCHASED FROM ANOTHER SOURCE (DISTRIBUTOR) THAT DID NOT CAUSE PROBLEMS. THE INVESTIGATION PERFORMED WAS BASED ON A REVIEW OF THE DEVICE HISTORY RECORDS AND TESTING OF RETAIN SAMPLE. THE OUTCOME OF THE QUALITY INVESTIGATION IS DELINEATED BELOW: A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. NO ISSUE WAS DETECTED. EACH ITEM AND LOT NUMBER: 2050 (LOT 1746), 2051 (LOT 1744), 2052 (LOT 1447), 2053 (1728) WERE SENT TO THIRD PARTY LABORATORY FOR TESTING IN ACCORDANCE WITH ISO 10993-5. RESULTS MEET REQUIREMENT OF THE STANDARD. BASED ON THE ABOVE INVESTIGATION, IT CAN BE CONSIDERED THAT PRODUCT WAS MANUFACTURED, PACKAGED, LABELED, INSPECTED AND RELEASED IN ACCORDANCE WITH PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 0

    THE FRAGRANCE ADDED TO THE MASKS CAUSED AN ALLERGIC REACTION. ADVERSE REACTIONS INCLUDED, CONGESTION, RESTRICTED BREATHING, WATERY EYES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN-PROGRESS.

    Description of Event or Problem · 1

    THE FRAGRANCE ADDED TO THE MASKS CAUSED AN ALLERGIC REACTION. ADVERSE REACTIONS INCLUDED, CONGESTION, RESTRICTED BREATHING, WATERY EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739610 MEDICOM SAFEMASK MASTER SERIES MASK FXX AMD MEDICOM INC. 1746, 1744, 1447, 1728 10686864040252

    Patients

    Seq Age Sex Outcome Treatment
    1 Other