inforMED
MalfunctionMSH

N95 MASK

Received Jul 10, 2020 · Event occurred Jun 30, 2020

Report MW5095493 · MDR key 10263540

Device

Generic name

Respirator, Surgical

Manufacturer

3m Company

Model number

1860

Lot number

B19299

Product problems

  • Product Quality Problem

Patient

77 YR

  • Fluid Discharge
  • Fluid Discharge

Narrative

Description of Event or Problem

I HAD SINUS SURGERY THIS PAST YEAR FOR SINUS POLYPS AND CHRONIC INFECTION. SINCE THE SURGERY I HAVE BEEN IRRIGATING MY SINUSES TWICE DAILY WITH A BUDESONIDE SOLUTION. SINCE THE IMMEDIATE POST-OP PERIOD, I HAVE HAD CLEAR EFFLUENT IN MY IRRIGATING SOLUTION UNTIL LAST NIGHT WHEN THE ENTIRE EFFLUENT CAME OUT GREEN LIKE PEA SOUP. THIS DID NOT RECUR TODAY. I BELIEVE THAT IT MAY BE FROM THE DYE USED BY 3M IN MANUFACTURING THEIR N95 MASK (3M 1860; NIOSH N95, LOT: B19299; (B)(4)). I HAVE NO SYMPTOMS REFERABLE TO THE NASAL SINUSES OTHER THAN A LONG TERM CHRONIC INTERMITTENT DRY COUGH, INCLUDING NO SENSE OF ABNORMAL SMELL, NO NASAL DISCHARGE AND NO SINUS TENDERNESS.