NAMUH 551201287 58286 59 17-132 D63RX GTV

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-04 for NAMUH 551201287 58286 59 17-132 D63RX GTV manufactured by Unk.

Event Text Entries

[5932984] Purchased (b)(6) made sun glasses and optical lenses from (b)(6) thru (b)(6) (address unk-remote site) and co-located optician (b)(6), representative for dr. (b)(6), on (b)(6) 2013. Shortly after purchasing the above (b)(6) made eye glass frames at (b)(6) i experienced my face having severe infections and eruptions from (b)(6) 2013 to (b)(6) 2015. On (b)(6) 2015, my wife and i noticed that the nose pieces on these (b)(6) made eye wear were disintegrating. We attempted to wipe the material off and reach a stabilizing point, but no such point was reached after dozens of rubbings. The infections start at the bridge of the nose (where the nose pieces are) and extend down both sides of my nose, around my mouth, down my chin and under my chin in a bright red semi-permanent deep ugly scarring of my skin. I have been to multiple dermatology appointments but did not realize that my glasses were alleged to cause these dermatology problems. The product description from (b)(6) optometry staff is as follows: order #(b)(6), 3(b)(6) 2013, (b)(4) "namuh" 551201287 shiny black sun glass frames 58286 black 59 17-132. $ (b)(6) paid by credit card. My wife and i have expressed our concerns to sam(b)(6) via 2 emails dated (b)(6) 2015 and in person at (b)(6) on (b)(6) 2015. We have been contacted twice in the last 24 hours by a (b)(6) independent representative. I believe i am the victim of a (b)(6) made defective medical device that has seriously damaged approximately 50% of my face, leaving disfiguring red scarring and skin problems.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5043027
MDR Report Key4834879
Date Received2015-06-04
Date of Report2015-06-04
Date of Event2015-06-02
Date Added to Maude2015-06-11
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 NameNAMUH 551201287 58286 59 17-132 D63RX GTV
Generic NameSUNGLASSES
Product CodeHQY
Date Received2015-06-04
Model NumberNAMUH 551201287 58286 59 17-132
Lot NumberSUN GLASSES
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2015-06-04

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