FOSTER GRANT 53 (SQUARE) 17-136 PD58 5MM - 2.00 CE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-26 for FOSTER GRANT 53 (SQUARE) 17-136 PD58 5MM - 2.00 CE manufactured by Unk.

Event Text Entries

[96230907] I purchased a pair of foster grant reading glasses sometime in (b)(6) of 2017. The info on the glasses on the left side is: (b)(4). Info on the right side is: foster grant 53 (square) 17-136 pd58 5mm - 2. 00 ce. My concern is every time i wear them they have black marks on both sides of the bridge of my nose where they rested. There seems to be something oozing out of the material they are made from. The material looks like a normal black injection molded plastic material that thousands of other products are made from with the exception that there is something leaching out onto my skin. Whatever it is it seems to come off with no rash or skin irritation that i can see. My husband has owned his own injection molding company in (b)(4) for over 40 years and has never seen any plastic injection molding material that would leech out any kind of stain on the human skin. He is concerned that the material used in molding these products in (b)(4) are contaminated and may cause numerous skin or other serious infections. I have kept the reading glasses just in case there has to be a material evaluation to see what exactly the makeup of this material really is. Please get back to me with any further info on this as soon as possible. No resolution, unless this effects my health in any way, other than finding out what is in this material that is leeching out onto my skin and hopefully bring this to the attention of foster grant to see if anyone else has this concern and they take steps to trace the origin of these glasses and take what ever steps are necessary to resolve this matter. Respectfully, (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5074259
MDR Report Key7148184
Date Received2017-12-26
Date of Report2017-11-16
Date of Event2017-07-15
Date Added to Maude2017-12-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameFOSTER GRANT 53 (SQUARE) 17-136 PD58 5MM - 2.00 CE
Generic NameMAGNIFYING SPECTACLES
Product CodeHOI
Date Received2017-12-26
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-26

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