MAUDE Adverse Event Report: INNONIX TECHNOLOGIES (SHENZHEN) CO LTD RESPOKARE N95 MASK; N95 RESPIRATOR WITH ANTIMICROBIAL/ANTIVIRAL AGENT

Model Number RK-200-3041A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sore Throat (2396); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/30/2020

Event Type  Injury  

Event Description

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).

• Brand Name: RESPOKARE N95 MASK
• Type of Device: N95 RESPIRATOR WITH ANTIMICROBIAL/ANTIVIRAL AGENT
• Manufacturer (Section D): INNONIX TECHNOLOGIES (SHENZHEN) CO LTD; HK
• MDR Report Key: 10642717
• MDR Text Key: 211029139
• Report Number: MW5097131
• Device Sequence Number: 1
• Product Code: ONT
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 10/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RK-200-3041A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 75