BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICOM SAFEMASK PREMIER ELITE

    MDR report key: 8003198 · Received October 24, 2018

    Report

    Report Number
    9611959-2018-00005
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    October 1, 2018
    Report Date
    October 24, 2018
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    FXX
    UDI-DI
    10686864109089
    PMA / PMN Number
    K051291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    A MEDWATCH WAS REPORTED TO THE FDA BY AMD MEDICOM WHICH REFERS TO MEDICOM MASK PRODUCT ITEM CODE 2046. THE FOLLOWING EVENT WAS REPORTED: "MON HYGIÉNISTE A FAIT UNE RÉACTION ALLERGIQUE RESPIRATOIRE IMPORTANTE. ELLE A ÉTÉ TRANSPORTÉE D'URGENCE A L'HÔPITAL. ELLE VA BIEN MAIS ON A EU TRÈS PEUR. ON TENTE DE SAVOIR CE QUI A PU PROVOQUER CETTE RÉACTION. ELLE ME DIT QUE LE SERREMENT À LA GORGE A DÉBUTÉ APRÈS QU'ELLE AIT RESPIRÉ PAR LA BOUCHE, DANS SON MASQUE (QU'ELLE VENAIT DE METTRE)" ENGLISH TRANSLATION: "CLIENT REPORTED THE FOLLOWING: MY HYGIENIST HAS HAD A SIGNIFICANT RESPIRATORY ALLERGIC REACTION. SHE WAS TRANSFERRED TO THE HOSPITAL URGENTLY. SHE IS FINE BUT WE WERE VERY SCARED. WE TRY TO FIND OUT WHAT COULD HAVE PROVOKED THIS REACTION. SHE TOLD ME THAT THE SORE THROAT BEGAN AFTER SHE BREATHED THROUGH HER MOUTH, IN HER MASK (SHE HAD JUST PUT)." CUSTOMER COMPLAINT WAS LOGGED AS PRODUCT QUALITY COMPLAINT 2019-QACOM-138. RETURN SAMPLES WERE RECEIVED AND 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 04-OCT-2018. THE FOLLOWING INFORMATION WAS RECEIVED: SUMMARY OF THE COMMUNICATION ON 16-OCT-2018: DATE OF EVENT: (B)(6) 2018. TYPE OF MEDICAL ATTENTION: BENADRYL CO. + O2 EMERGENCY TRANSPORTATION TO THE HOSPITAL SPENT SEVERAL HOURS WAITING, DID NOT SEE A DOCTOR. SYMPTOMS: PRICKLING IN THE THROAT, ACUTE AND SUDDEN RESPIRATORY DIFFICULTY, RED PLAQUES ON THE NECK, SWEATING AND NAUSEA OCCURRED 1 MIN AFTER INHALING THROUGH THE MOUTH INTO THE NEW MASK. DURATION OF THE ADVERSE REACTION: 1 HOUR. THE INVESTIGATION PERFORMED WAS BASED ON A REVIEW OF THE DEVICE HISTORY RECORDS AND TESTING OF RETURN SAMPLE. THE OUTCOME OF THE QUALITY INVESTIGATION IS DELINEATED BELOW: A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. NO ISSUE WAS DETECTED. ITEM AND LOT NUMBER: 2046 (10) 1815 WAS SENT TO THIRD PARTY LABORATORY TESTING. RESULTS INDICATED COMPLIANCE TO REQUIREMENT OF (B)(4) STANDARD. BASED ON THE ABOVE INVESTIGATION AND TESTING RESULTS OF RETURN SAMPLE, IT CAN BE CONSIDERED THAT THE PRODUCT WAS MANUFACTURED, PACKAGED, LABELED, INSPECTED AND RELEASED IN ACCORDANCE WITH PRODUCT SPECIFICATION.

    Description of Event or Problem · 0

    CLIENT REPORTED THE FOLLOWING: MON HYGIÉNISTE A FAIT UNE RÉACTION ALLERGIQUE RESPIRATOIRE IMPORTANTE. ELLE A ÉTÉ TRANSPORTÉE D'URGENCE A L'HOPITAL. ELLE VA BIEN MAIS ON A EU TRES PEUR. ON TENTE DE SAVOIR CE QUI A PU PROVOQUER CETTE RÉACTION. ELLE ME DIT QUE LE SERREMENT A LA GORGE A DÉBUTÉ APRES QU'ELLE AIT RESPIRÉ PAR LA BOUCHE, DANS SON MASQUE (QU'ELLE VENAIT DE METTRE). TYPE D'ATTENTION MÉDICALE: BÉNADRYL EN CO. + O2 TRANSPORT EN URGENCE L'HÔPITAL A PASSÉ PLUSIEURS HEURE À ATTENDRE, PAS VU DE MEDECIN. SYMPTÔMES: PICOTMENTS À LA GORGE, DIFFICULTÉ RESPIRATOIRE AIGUE ET SUBITE, PLAQUES ROUGES DANS LE COU, SUEUR ET NAUSÉES SURVENU 1 MIN APRÈS AVOIR ASPIRÉ PAR LA BOUCHE DANS LE MASQUE NEUF. DURÉE DE L'EFFET INDÉSIRABLE: 1 HEURE. ENGLISH TRANSLATION: CLIENT REPORTED THE FOLLOWING: MY HYGIENIST HAS HAD A SIGNIFICANT RESPIRATORY ALLERGIC REACTION. SHE WAS TRANSFERRED TO THE HOSPITAL URGENTLY. SHE IS FINE BUT WE WERE VERY SCARED. WE TRY TO FIND OUT WHAT COULD HAVE PROVOKED THIS REACTION. SHE TOLD ME THAT THE SORE THROAT BEGAN AFTER SHE BREATHED THROUGH HER MOUTH, IN HER MASK (SHE HAD JUST PUT). TYPE OF MEDICAL ATTENTION: BENADRYL CO. + O2 EMERGENCY TRANSPORTATION TO THE HOSPITAL. SPENT SEVERAL HOURS WAITING, DID NOT SEE A DOCTOR. SYMPTOMS: PRICKLING IN THE THROAT, ACUTE AND SUDDEN RESPIRATORY DIFFICULTY, RED PLAQUES ON THE NECK, AND SWEATING AND NAUSEA OCCURRED 1 MIN AFTER INHALING THROUGH THE MOUTH INTO THE NEW MASK. DURATION OF THE ADVERSE REACTION: 1 HOUR.

    Description of Event or Problem · 1

    CLIENT REPORTED THE FOLLOWING: MY HYGIENIST HAS HAD A SIGNIFICANT RESPIRATORY ALLERGIC REACTION. SHE WAS TRANSFERRED TO THE HOSPITAL URGENTLY. SHE IS FINE BUT WE WERE VERY SCARED. WE TRY TO FIND OUT WHAT COULD HAVE PROVOKED THIS REACTION. SHE TOLD ME THAT THE SORE THROAT BEGAN AFTER SHE BREATHED THROUGH HER MOUTH, IN HER MASK (SHE HAD JUST PUT). TYPE OF MEDICAL ATTENTION: BENADRYL CO. + O2; EMERGENCY TRANSPORTATION TO THE HOSPITAL; SPENT SEVERAL HOURS WAITING, DID NOT SEE A DOCTOR. SYMPTOMS: PRICKLING IN THE THROAT; ACUTE AND SUDDEN RESPIRATORY DIFFICULTY; RED PLAQUES ON THE NECK; SWEATING AND NAUSEA OCCURRED 1 MIN AFTER INHALING THROUGH THE MOUTH INTO THE NEW MASK. DURATION OF THE ADVERSE REACTION: 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843071 MEDICOM SAFEMASK PREMIER ELITE MASK FXX AMD MEDICOM INC. (10)1815 10686864109089

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other