MEDICOM SAFEMASK MASTER SERIES 2058Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10686864047671), received between Oct 23, 2020 and Oct 23, 2020 — classified as 1 injury.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INCIDENT WAS REPORTED TO AMD MEDICOM ON 24-SEP-2020 FOR MEDICOM SAFEMASK MASTER SERIES L3 ITEM 2085: "DURING GENERAL DENTAL DUTIES ROUGHLY 6 STAFF MEMBERS WERE ALL EXPERIENCING SOME TYPE OF REACTION FROM THESE MASKS. MOST EXPERIENCED A RASH ON THEIR FACE ON THE BOTTOM PART OF THEIR CHIN AS WELL AS NEAR THEIR MOUTH WHILE ONE OF THE STAFF MEMBERS AS THEY WERE BREATHING IN FELT THAT THE FIBERS INSIDE THE MASK GAVE HER SHORTNESS OF BREATH, MAKING IT HARD TO BREATHE. SHE WENT TO THE HOSPITAL WHERE SHE WAS GIVEN BENADRYL AND WAS MONITORED. THE SAME DAY SHE WENT BACK TO WORK. ONCE ALL STOPPED WEARING THE RASH HAD CLEARED. NO STAFF SPECIFICS WERE PROVIDED AND AS THEY HAVE ALREADY SENT BACK USING LABEL THAT WAS PROVIDED, THEY COULD NOT PROVIDE THE LOT NUMBER OF THE MASKS. THIS WAS THE FIRST TIME USING THESE TYPES OF MASKS."

  Patient problems: Dyspnea; Rash

  MAUDE report 10730882 ↗