SMITH *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-18 for SMITH * manufactured by Bondet.

Event Text Entries

[16365519] Pt was wearing sunglasses while riding his bicycle in 10/96. He fell and hit his face on the ground breaking the frame of the glasses. He cut his forehead and received 8 stitches. Mfr believes the injury was caused by the person falling on his face and not by their product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3022808-1997-00001
MDR Report Key71283
Date Received1997-02-18
Date of Report1997-02-14
Date of Event1996-10-12
Date Facility Aware1997-02-12
Report Date1997-02-14
Date Added to Maude1997-02-27
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSMITH
Generic NameSUNGLASSES
Product CodeHQY
Date Received1997-02-18
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device Availability*
Device Age6 MO
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key71178
ManufacturerBONDET
Manufacturer Address29, RUE JJ ROUSSEAU 01104 OYONNAX (AIN) FR


Patients

Patient NumberTreatmentOutcomeDate
10 1997-02-18

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