BED SPECTACLES MAGNIFYING GLASS PRISM GLASSES, ITEM #228

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-10 for BED SPECTACLES MAGNIFYING GLASS PRISM GLASSES, ITEM #228 manufactured by Unk.

Event Text Entries

[119948356] I received a pair of ls&s bed spectacles, item # 228, drop shipped from ls&s products, federal id # (b)(4), by an order placed by the (b)(6). They are intended to allow viewing or reading while lying on your back or to not bend you neck downward. Out of the box the frames are bent and distorted with unstable glass prisms mounted in the frames. The prisms mounted in the frames are misaligned along the top horizontal edge by 3/8 inch, looking as if the left and right sides are bent downward, and the frames are dished inward at the nose rest by 1/4 inch. The misalignment of the prisms cause the viewing image to be overlapped at an angle and the distortion makes them useless for their intended purpose, and developed an instant headache and nausea from wearing them. They are dangerous to a person's vision because both prisms each with a razor sharp edge are actually protruding outward out of the rear of the frame towards the eye. The edges are razor sharp and it could easily cut the eyeball or slice off eyes, cornea, and quite easily blinding the wearer in that unfortunate eye. The glass prisms are not adequately secured in the frame, and there is no safeguard for the prisms retention in the frame to prevent severe eye injury if the prisms fall into the eye from their intended use. This product does not function as advertised, is poorly manufactured, and is and dangerous to the users' vision, this product should be banned from import and government purchase. Document (b)(4). Product description: ls&s bed spectacles #228 used for viewing tv or reading when laying down in bed or sitting without bending your neck. Consisting of 2 glass prisms mounted in a plastic frame, 5 3/8 inch wide and 5 1/2 inches deep. Mfr website url: lssproducts. Com.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5079682
MDR Report Key7864300
Date Received2018-09-10
Date of Report2018-08-21
Date of Event2018-08-20
Date Added to Maude2018-09-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
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 NameBED SPECTACLES MAGNIFYING GLASS
Generic NameBED SPECTACLES MAGNIFYING GLASS
Product CodeHOI
Date Received2018-09-10
Model NumberPRISM GLASSES, ITEM #228
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-10

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