SMITH *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-10 for SMITH * manufactured by Bondet.

Event Text Entries

[70038] On september 10, 1997 the dist rec'd a letter from the complainant the dist of the injury. The complainant was wearing slider sl2 sunglasses while riding her bicycle. She fell and hit the ground breaking the frame of the glasses. She rec'd a cut and required plastic surgery. The dist believes the injury was caused by the person falling on her face and not by the dist's product.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3022808-1997-00002
• MDR Report Key: 118466
• Date Received: 1997-09-10
• Date of Report: 1997-09-10
• Date Facility Aware: 1997-09-10
• Report Date: 1997-09-10
• Date Added to Maude: 1997-09-11
• 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: 1997-09-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: 6 MO
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 116166
• Manufacturer: BONDET
• Manufacturer Address: 29, RUE JJ ROUSSEAU OYONNAX (AIN) FR 01104

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-09-10