READING GLASSES UNK 0 21087 55780 5,0 21087 557843

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-14 for READING GLASSES UNK 0 21087 55780 5,0 21087 557843 manufactured by Bci.

Event Text Entries

[17490245] Rptr to dollar gen at their website link that rptr had purchased approx 9 pairs of reading glasses over the past 2-3 yrs, and of those, about four or 5 pair had broken, with two pair breaking spontaneously while being worn. One pair suddenly snapped just below the right hinge "buttress" and the right lens popped out and fell into lap. This occurred while operating a motor vehicle and while was disconcerting, did not result in any collision or damage. The second spontaneous break occurred while watching television and the temple piece just broke near the hinge and the glasses fell from face. In neither of these instances were the glasses being placed on face or removed. They were simply being worn normally. The other failures consisted of a temple piece breaking just where it curves over the ear, and in two others, the hinges failed at the plastic holes where the temple piece is screwed to the frame. These were fatigue cracks which progressed relatively slowly, and resulted in failure while the glasses were being removed or applied. All of the glasses purchased were brown, "tortoise shell" half frame reading glasses. Although there are slight cosmetic differences between some of the glasses, they are all similar if not identicial. According to rptr should these frames fail spontaneously as they did with rptr at an inopportune time, the failure could lead to serious distraction with resulting injury or death. Rptr questions whether or not these items meet the requirements for importation and sale in the united states.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002880
MDR Report Key301028
Date Received2000-09-14
Date of Report2000-09-14
Date of Event1998-01-01
Date Added to Maude2000-10-23
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 Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameREADING GLASSES
Generic NameREADING GLASSES MADE IN CHINA
Product CodeHOI
Date Received2000-09-14
Model NumberUNK
Catalog Number0 21087 55780 5,0 21087 557843
Lot NumberNI
ID NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key291348
ManufacturerBCI
Manufacturer Address* SKOKIE IL 60076 US


Patients

Patient NumberTreatmentOutcomeDate
10 2000-09-14

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