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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZEN NEWSTAR OPTICAL ELECTRONIC TECHNOLOGY CO., LTD DISPOSABLE PROTECTIVE MASK,NB-HF01,PROTECTIVE MASK,NB-YY01,NB-YY02,NB-YY03 FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER II

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SHENZEN NEWSTAR OPTICAL ELECTRONIC TECHNOLOGY CO., LTD DISPOSABLE PROTECTIVE MASK,NB-HF01,PROTECTIVE MASK,NB-YY01,NB-YY02,NB-YY03 FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER II Back to Search Results
Model Number DISPOSABLE PROTECTIVE MASK
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2020
Event Type  Injury  
Event Description

In the month of (b)(6) i have purchase 100,000 pcs 3ply mask from (b)(6) to my (b)(6) factory for my factory usage due to covid-19. This company claims itself to have been certified with fda. They have shown me packaging boxes and company brochure all with fda labelled, which i have then proceeded to make a bulk purchase of masks from this manufacturer. To my surprise, when i received the masks in (b)(6), some of the masks are dirty, dusty and with unknown stain, and not fit to be used. Only later, i found out that they are not actually fda certified during the time when they sold the masks to me. When i started to question them, they provided me with a fda certificate (dated april 7th 2020) in an attempt to silent me. I felt cheated, this factory has misled me (consumer) to buy their product before they even officially received any fda certification. And the problem is, why would fda even grant certification to such factory that: fraudulently misused fda logo; and do not have proper facility or procedure to ensure cleanliness of masks produced ( dirty and not even fit to use ). Is this fda standard? this company is certified with fda under (b)(6). Beside that, i was also confused by the fact that their fda certificate which belongs to the company name: (b)(4); operator number: (b)(4), was repeatedly misused under a different company name: (b)(4) in their company profile for sales pitch - is this even authorised and legal? i hope such dishonesty of (b)(4) manufacturer should strongly and firmly be opposed, action should be taken by fda authority because this surely is jeopardizing fda credibility internationally. Fda safety report id# (b)(4).

 
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Brand NameDISPOSABLE PROTECTIVE MASK,NB-HF01,PROTECTIVE MASK,NB-YY01,NB-YY02,NB-YY03
Type of DeviceFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER II
Manufacturer (Section D)
SHENZEN NEWSTAR OPTICAL ELECTRONIC TECHNOLOGY CO., LTD
MDR Report Key10004527
MDR Text Key189451210
Report NumberMW5094273
Device Sequence Number1
Product Code QKR
Combination Product (Y/N)N
Reporter Country CodeMY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 04/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberDISPOSABLE PROTECTIVE MASK
Device Catalogue NumberNIL
Device LOT Number19-03-2020
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/27/2020 Patient Sequence Number: 1
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