MEDICOM SAFEMASK PREMIER 2046Recalls & reported problems
AMD Medicom Inc · SAFEMASK PREMIER ELITE EARLOOP PINK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10686864109089), received between Oct 24, 2018 and Oct 24, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
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 S
Patient problems: Reaction
MAUDE report 8003198 ↗
Other Mask, surgical devices
- Halyard 47117O&M Halyard, Inc. · Mask, surgical1 recall12 reports
- Halyard 47147O&M Halyard, Inc. · Mask, surgical1 recall1 report
- Henry Schein 5702448Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Criterion 5703281Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Halyard 47500O&M Halyard, Inc. · Mask, surgical1 recall0 reports
- Medline NON27410Medline Industries, Inc. · Mask, surgical14 reports
- UltraTM Earloop Mask GCFCXSCrosstex International, Inc. · Mask, surgical8 reports
- UltraTM Sensitive FogFreeTM Earloop Mask w/ Secure FitTM GCFCXSSFCrosstex International, Inc. · Mask, surgical5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page