inforMED
MalfunctionMSH

N95 MASKS

Received Jul 7, 2022 · Event occurred Jun 20, 2022

Report MW5110750 · MDR key 14957888

Device

Generic name

Respirator, Surgical

Manufacturer

3m Company

Lot number

A21335

Product problems

  • Break

Patient

43 YR · Male

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

STRAPS BROKE OFF OF 3M N95 MASKS TWICE 3M, LOT# A21335 EXPOSED TO AIRBORNE PATHOGENS FOR AROUND 1HR. E-MAILED INCIDENT TO 3M ONLY TO RECEIVE REPLY CASUALLY ADDRESSING ME BY FIRST NAME AND OFFERING REPLACEMENT PRODUCT. FDA SAFETY REPORT ID# (B)(4).