PERFORMANCE RADIAL 37-0081A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-28 for PERFORMANCE RADIAL 37-0081A manufactured by Performance, Inc..

Event Text Entries

[18561631] While mountain biking, pt had an accident and struck the ground. Pt's helmet and right should hit. Pt then felt something "slipping" over their face and fainted for a second. When they stood up, pt felt something in front of their mouth. Pt took off their glove and put their right hand on it when they pulled their hand away, pt found it was covered with blood. Pt determined that their face had been cut and was hanging in front of their mouth. Pt thought that they had hit a rock and that it had cut their face. Pt taped gauze pads to their face then drove 60 miles to a hosp. A surgeon was called in who after 3 hrs of surgery, had reattached pt's face. Later, on 2/9, pt returned to the scene of the accident and found the biking sunglasses they were wearing on the side of the trail - along with the prescription inserts that they had. In looking at the glasses, pt realized what they had suspected; that the glasses were driven into their face and had cut off their nose approx from cheek-to-cheek. The glasses are sold by performance, inc. Of chapel hill, nc under their brand name, performance "radial" they are a knock off of the popular bolle and smoth moab type glasses. The sunglass component was severely scratched, but not broken - its a wrap around glass that has no frame component on the bottom of the sunglass part - see their web site at www. Performancebike. Com-. From the blood on the glasses and the scratched lens, pt determined that it was the sunglass lens that severed their face. These may be "fashion" type glasses, but they are being marketed for use in sporting events. Pt spent the night in the hosp, and missed a week of work following the surgery. Pt still has no feeling in the right side of their face above the lip because the nerves were severed as well. The problem is pervasive - it is applicable to other sunglasses that do not have a frame component at the bottom, such as those that performance sells by bolle and smith.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1018521
MDR Report Key271570
Date Received2000-03-28
Date of Report2000-03-28
Date of Event2000-02-05
Date Added to Maude2000-04-03
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 Sequence Number: 1

Brand NamePERFORMANCE RADIAL
Generic NameSUNGLASSES
Product CodeHQZ
Date Received2000-03-28
Model NumberRADIAL
Catalog Number37-0081A
Lot Number*
ID Number00-9303A
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key262893
ManufacturerPERFORMANCE, INC.
Manufacturer AddressONE PERFORMANCE WAY CHAPEL HILL NC 27514 US

Device Sequence Number: 2

Brand NamePERFORMANCE RADIAL
Generic NameSUNGLASSES
Product CodeHQZ
Date Received2000-03-28
Model NumberRADIAL
Catalog Number37-0081A
Lot Number*
ID Number00-1792A
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key262905
ManufacturerPERFORMANCE, INC.
Manufacturer AddressONE PERFORMANCE WAY CHAPEL HILL NC 27514 US

Device Sequence Number: 3

Brand NamePERFORMANCE RADIAL
Generic NameSUNGLASSES
Product CodeHQZ
Date Received2000-03-28
Model NumberRADIAL
Catalog Number37-0081A
Lot Number*
ID Number00-4078B, ETC
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No3
Device Event Key262907
ManufacturerPERFORMANCE, INC.
Manufacturer AddressONE PERFORMANCE WAY CHAPEL HILL NC 27514 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2000-03-28

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