MEDLINE
Received Jun 25, 2026 · Event occurred Jan 23, 2026
Report 1417592-2026-03236 · MDR key 25626384
Device
Generic name
Dbd-mask,face,earloops, Blue,50ct
Manufacturer
Medline Industries, LpCatalog number
CVS469682
Product problems
- Loss of or Failure to Bond
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT "A PRODUCT THAT SHE PURCHASED IN THE STORE BECAUSE ITS QUALITY IS GOING "DOWNHILL", THE NOSE PIECE COMES OUT AND IT'S PRACTICALLY WORTHLESS, AND NOT USER FRIENDLY". THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS PART OF RETROSPECTIVE REVIEW ACTIVITIES, WHICH INCLUDE REVIEW OF HISTORICAL DATA IN ACCORDANCE WITH REGULATIONS AT 21 CFR PART 803. THE INFORMATION INCLUDED IN THIS MDR REFLECTS THE INFORMATION REASONABLY KNOWN TO THE MANUFACTURER AT THE TIME OF THIS RETROSPECTIVE REVIEW AND SUBMISSION.
Description of Event or Problem
IT WAS REPORTED THAT "A PRODUCT THAT SHE PURCHASED IN THE STORE BECAUSE ITS QUALITY IS GOING "DOWNHILL", THE NOSE PIECE COMES OUT AND IT'S PRACTICALLY WORTHLESS, AND NOT USER FRIENDLY".