BOROSCOPE BOROSCOPE #3 GLASSES IN FIT-OVER FRAME (HARD GLASS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-13 for BOROSCOPE BOROSCOPE #3 GLASSES IN FIT-OVER FRAME (HARD GLASS manufactured by Phillips Safety Products.

Event Text Entries

[42947298] There is a line of lenses being manufactured by phillips, that are not up to standards. These lenses are used in glasses specifically made for lamp workers/glassblowers. The issue i had was with phillips lenses in another companies frame. The lenses do not have the sufficient protection against the sodium flares that come when working with glass. That is the point of these lenses. To block those flares and protect your eyes. I am not sure when these lenses were manufactured and i bought the glasses a year ago and who knows how long they sat on the shelf before then. I was unaware of how dangerous they were until i had gotten a new pair of glasses with a different companies lens and did not see the same flare ups. This information has been passed around via social media at t his point to keep other glassblowers safe. Retailer: (b)(6). Retailer state: (b)(6). Purchase date: (b)(6) 2015; this date is an estimate. The product was damaged before the incident: yes. The product was modified before the incident: no. Explanation: item was not manufactured properly, phillips has not taken it upon themselves to recall the lenses. Other brands that use their lenses have issued recalls. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5061713
MDR Report Key5580894
Date Received2016-04-13
Date of Report2016-03-31
Date of Event2016-03-17
Date Added to Maude2016-04-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBOROSCOPE
Generic NameBOROSCOPE LAMPWORKING GLASSES WITH PHILLIPS BRAND LENSES
Product CodeHOY
Date Received2016-04-13
Model NumberBOROSCOPE #3 GLASSES IN FIT-OVER FRAME (HARD GLASS
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPHILLIPS SAFETY PRODUCTS


Patients

Patient NumberTreatmentOutcomeDate
10 2016-04-13

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