GUESS 402 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-15 for GUESS 402 * manufactured by *.

Event Text Entries

[20933031] This letter explains formal complaint about the distribution of a product that poses a danger to young children by guss brand eyeware. Reporter feels this co seems to have no concern at all for the dangers posed by its product to children. Pt used the frame for almost a year without problems until the day they slipped off a couch at home and banged their head on the carpeted floor. Eyeglass frame was damaged in the fall, about 0. 5 meters, but of more concern were the puncture wounds caused at their temples by the frame. On examination of the frame reporter noticed that the design has what appeared to be an inherent flaw. The hinge possessed an almost razor sharp edge that was responsible for the puncture wounds. Reporter immediately replaced the glasses and frame with a pair from the same manufacturer to assist with lens fitting that has no sharp and dangerous edges. Reporter checked their own eyeglasses and those of their spouse to see if this kind of sharp edge existed on all their glasses. It did not. At the optometrist they went through all the children's frames there and found no other brand of frame that exhibited these dangerous corners. Even other eyeglass frames from the same manufacturer showed no such sharp edges. To his credit the optometrist also expressed surprise and concern on being made aware of this problem. Reporter sent clear photographs that explained the problem to the distributor, and suggested to them that the frames in question were unsafe and unsuitable for children, and should be withdrawn from sale, and that current users be informed in regard to a potential safety issue. Reporter also advised them that we had replaced the dangerous frame and would require reimbursement and may need to seek medical attention for pt, if the scars caused by the frame did not recede. The distributor exhibited little or no concern for pt's injury even when presented with the clear photographic evidence and after a five business day wait had not yet returned call with an explanation and confirmation that other children/parents be warned of the potential danger. Reporter called back and was told that nothing would be done and that there was no problem to address. Reporter was shocked at the callousness of their response. Reporter feels children are the least protected individuals in society as it is over, it is up to all concerned parents to act to ensure that young children are protected from damagerous product flaws. Reporter feels the pt could have been much more severely injured. To receive the brush off and to be told that nothing would be done is shocking. Reporter would advise parents to avoid all guess brand eyeglass frames until they acknowledge this problem and advise parents of the potential damages. Reporter feels this kind of dismissive callousness to an obvious problem is unethical and unacceptable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1026772
MDR Report Key428600
Date Received2002-11-15
Date of Report2002-11-15
Date of Event2002-11-08
Date Added to Maude2002-11-22
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 FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameGUESS
Generic NameEYEGLASS FRAME MODEL 402
Product CodeHQZ
Date Received2002-11-15
Model Number402
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key417632
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2002-11-15

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