MalfunctionMSH
1860 N95 MASK
Received Mar 17, 2021 · Event occurred Feb 4, 2021
Report 11503796 · MDR key 11503796
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
RECEIVED 3M BULLETIN REGARDING POTENTIAL FRAUD WITH SEVERAL MODELS OF THE N95 PARTICULATE RESPIRATORS. INSTRUCTED BY 3M TO SEQUESTER AFFECTED LOTS AND SUBMIT INFORMATION RELATED TO THE PRODUCT AND ITS PURCHASE SO THE 3M FRAUD COULD FOLLOW UP. OUR HEALTH SYSTEM HAD A LARGE AMOUNT OF ONE OF THE LOTS AT OUR WAREHOUSE THAT HAD NOT YET BEEN DISTRIBUTED.