2.00 READING GLASSES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-05 for 2.00 READING GLASSES manufactured by Diamond Vision, Inc..

Event Text Entries

[5950336] Caller purchased a pair of reading glasses on (b)(6) 2015 from hardware store in michigan. On (b)(6) 2015 she picked the glasses up when drew back because she had touched on a very sharp area at the nose piece. On each side of the bar connecting the glass eye area, there is a sharp pointed object. There are two other sharp pointed objects on each side of the nasal grips of the glasses. These sharp pieces are on the side that is placed on the face. Not on the outside. On (b)(6) 2015 the caller returned to the place of purchase to return the glasses, she met with (b)(6) who is the store manager. She explained to him what had happened with her pair of glasses then they both searched the racks looking for glasses with the same sharp area. They both searched the racks for other glasses with these sharp pointed pieces, (b)(6) found none but the caller found four pairs and gave them to him. He informed her that he was planing to put them in his safe and notify the store's corporate office. She is reporting this as a laceration hazard. There are no injuries known to report. She has not contacted the manufacturer because they are unk to her and she has not contacted the distributor because they are in (b)(4). (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5042556
MDR Report Key4758568
Date Received2015-05-05
Date of Report2015-03-20
Date of Event2015-03-17
Date Added to Maude2015-05-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name2.00 READING GLASSES
Generic NameNONE
Product CodeHQZ
Date Received2015-05-05
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerDIAMOND VISION, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2015-05-05

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