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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
Medical Device Problem Code Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/30/2020
Type of Reportable Event Serious Injury
Event or Problem 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 Name
DISPOSABLE PROTECTIVE MASK,NB-HF01,PROTECTIVE MASK,NB-YY01,NB-YY02,NB-YY03
Common Device Name
FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER II
Manufacturer (Section D)
SHENZEN NEWSTAR OPTICAL ELECTRONIC TECHNOLOGY CO., LTD
MDR Report Key10004527
Report NumberMW5094273
Device Sequence Number13186084
Product Code QKR
Combination Product (Y/N)N
Initial Reporter CountryMY
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Expiration Date03/13/2022
Device Model NumberDISPOSABLE PROTECTIVE MASK
Device Catalogue NumberNIL
Device Lot Number19-03-2020
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/27/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age30 YR
Patient Weight47
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