MAUDE Adverse Event Report: JIANGSU EXCELLENCE MEDICAL SUPPLIES CO., LTD SINGLE-USE MASK; ACCESSORY, SURGICAL APPAREL

Model Number EAR-HANGING

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

Patient Problems Erythema (1840); Skin Burning Sensation (4540)

Event Date 09/17/2020

Event Type  Injury  

Event Description

I wore a disposable mask (made by some company in (b)(6)) from a box of 50 i bought at (b)(6) pharmacy to wear while feeding my special needs child.Immediately i felt burning where the top of the mask went over my face, that seam where the wire goes.I hurried to finish and removed the mask no more than five minutes from when i put it on.The burning kept increasing, and all across my cheeks and nose at the top where the mask is secured together turned my face red in a line where the seam had touched.I washed my face off immediately, and had to a second time because the reaction continued and it seemed there was a sticky residue stuck on my skin, which made me concerned about it being a vinyl material because i'm allergic to vinyl.Over an hour later the redness has gone down some, but my face still feels like it's been chemically burned.It hurts.I took a picture of my face five minutes after i washed it the first time and have pictures of the product.Fda safety report id # (b)(4).

• Brand Name: SINGLE-USE MASK
• Type of Device: ACCESSORY, SURGICAL APPAREL
• Manufacturer (Section D): JIANGSU EXCELLENCE MEDICAL SUPPLIES CO., LTD
• MDR Report Key: 10566350
• MDR Text Key: 208359039
• Report Number: MW5096778
• Device Sequence Number: 1
• Product Code: LYU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/17/2022
• Device Model Number: EAR-HANGING
• Device Lot Number: 20200418
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 47 YR
• Patient Weight: 59