EYEGLASSES EYEWEAR FRAMES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-23 for EYEGLASSES EYEWEAR FRAMES manufactured by Unk.

Event Text Entries

[106433966] On (b)(6) 2018 the consumer stated that she had the reading glasses on for about an hour. She felt an itching sensation while wearing the glasses. When she woke up the next morning, she discovered that there was a burn on both sides of her nose from the nosepads. Injury information: injury, no first aid or medical attention received. Purchase date: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5076670
MDR Report Key7454097
Date Received2018-04-23
Date of Report2018-04-06
Date of Event2018-03-29
Date Added to Maude2018-04-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationNURSING ASSISTANT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEYEGLASSES EYEWEAR FRAMES
Generic NameFRAME SPECTACLE
Product CodeHQZ
Date Received2018-04-23
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-23

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