MEDLINE
Received Jun 1, 2026 · Event occurred May 4, 2026
Report 1417592-2026-01987 · MDR key 25355880
Device
Generic name
Mask, Loop, Blue, Lvl 1
Manufacturer
Medline Industries, LpCatalog number
NON27378Z
Lot number
664251200
Product problems
- Material Split, Cut or Torn
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT CUSTOMER TRIED ON AT LEAST 10 MASKS AND THE EAR LOOPS JUST FALL OFF; THE ITEMS ARE DEFECTIVE. 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.
Description of Event or Problem
IT WAS REPORTED THAT CUSTOMER TRIED ON AT LEAST 10 MASKS AND THE EAR LOOPS JUST FALL OFF; THE ITEMS ARE DEFECTIVE.