inforMED
InjuryONT

RESPOKARE N95 MASK

Received Oct 6, 2020 · Event occurred Sep 30, 2020

Report MW5097131 · MDR key 10642717

Device

Generic name

N95 Respirator With Antimicrobial/antiviral Agent

Model number

RK-200-3041A

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

66 YR

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

Narrative

Description of Event or Problem

USE OF N95 MASK BRAND NAME RESPOKARE. PATIENT DEVELOPED HOARSENESS ON DAY TWO USING RESPOKARE N95 MASK FOR A PERIOD OF 4 HOURS PER DAY. BY DAY FOUR PATIENT HAD NEARLY COMPLETE LOSS OF VOICE. THIS CONDITION REMAINED UNCHANGED FOR FOUR MORE DAYS. ON DAY TEN PATIENT DISCONTINUED USE OF RESPOKARE BRAND MASK AND BEGAN USING 3M 9210 NIOSH N95 MASK IN PLACE OF RESPOKARE MASK. WITHIN 3 HOURS PATIENTS VOICE BEGAN RECOVERING. WITHIN 24 HOURS AFTER SWITCHING TO 3M N95 MASK PATIENT RECOVERED APPROXIMATELY 70% OF NORMAL VOICE LEVEL. PATIENT PURCHASED A TOTAL OF 20 RESPOKARE BRAND N95 MASKS FROM N95MASKCO.COM WHICH WERE MAILED FROM (B)(6). PATIENT REUSED EACH RESPOKARE MASK FOR A PERIOD OF 12 TOTAL HOURS EACH BEFORE SWITCHING TO A NEW RESPOKARE BRAND MASK. FDA SAFETY REPORT ID# (B)(4).