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 Number: 3022808-1997-00001
• MDR Report Key: 71283
• Date Received: 1997-02-18
• Date of Report: 1997-02-14
• Date of Event: 1996-10-12
• Date Facility Aware: 1997-02-12
• Report Date: 1997-02-14
• Date Added to Maude: 1997-02-27
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SMITH
• Generic Name: SUNGLASSES
• Product Code: HQY
• Date Received: 1997-02-18
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Age: 6 MO
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 71178
• Manufacturer: BONDET
• Manufacturer Address: 29, RUE JJ ROUSSEAU 01104 OYONNAX (AIN) FR

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-02-18