inforMED
MalfunctionMSH

3M 8511 RESPIRATOR MASK

Received Apr 13, 2021 · Event occurred Feb 10, 2021

Report MW5100752 · MDR key 11663886

Device

Generic name

Respirator, Surgical

Manufacturer

3m Company

Model number

8511

Product problems

  • Device Emits Odor

Patient

Not reported

  • Burning Sensation
  • Burning Sensation

Narrative

Description of Event or Problem

I HAVE USED 3M 8511 MASKS FOR MANY YEARS WITHOUT AN ISSUE. ALL OF A SUDDEN THE MASKS THAT I BUY NOW SMELL LIKE CHEMICALS AND CAUSE A BURNING SENSATION ON MY SKIN WHEN I TRY THEM ON. THE CHEMICAL SMELL IS SO STRONG THAT IF YOU TAKE A MASK OUT OF THE BOX AND PUT IT IN A ROOM WITHIN MINUTES THE WHOLE ROOM WILL SMELL LIKE CHEMICALS AND BECAUSE THE SMELL IS SO STRONG I CANNOT WEAR THE MASKS. I HAVE CONTACTED 3M ABOUT THIS NUMEROUS TIMES AND THEY DO NOT SEEM TO CARE AND EVEN TOLD ME THROUGH EMAIL THAT THEY KNOW THEIR MASKS SMELL LIKE CHEMICALS AND THEY DON'T WANT TO FIX IT. THE QUALITY CONTROL AT 3M SEEMS TO BE NONEXISTENT; 3M ASKED ME TO SEND A MASK TO THEM FOR ANALYSIS WHICH I DID AND THEY TOLD ME I WOULD GET THE RESULTS IN A WEEK AND NOW THEY WON'T GIVE ME THE RESULTS OF THE ANALYSIS AND HAVE IGNORED MY EMAILS ASKING FOR IT. I SUSPECT THAT THE ANALYSIS SHOWED CHEMICALS ON THE MASKS AND THEY DON'T WANT TO TELL ME. I CAN SEND A MASK TO YOU FOR ANALYSIS IF YOU WANT. I WOULD ALSO LIKE FOR FDA TO DO AN INSPECTION OF THE FACTORY THAT MAKE THESE MASKS. FDA SAFETY REPORT ID# (B)(4).