SMITH *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-09-30 for SMITH * manufactured by Bondet.

Event Text Entries

[82897] On 9/30/98 dist rec'd a letter advising of the injury. Pt was wearing slider sl2 sunglasses while riding his mountain bike. He fell and hit the ground breaking the frame of the glasses. He rec'd a cut that required 9 stitches. Dist believes the injury was caused by the person falling and not by the product.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3022808-1998-00002
• MDR Report Key: 189680
• Date Received: 1998-09-30
• Date of Report: 1998-09-30
• Date of Event: 1998-09-01
• Date Facility Aware: 1998-09-30
• Report Date: 1998-09-30
• Date Added to Maude: 1998-10-01
• 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
• Reporter Occupation: UNKNOWN
• 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: HQZ
• Date Received: 1998-09-30
• Returned To Mfg: 1998-09-30
• 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: 184333
• Manufacturer: BONDET
• Manufacturer Address: 29, RUE JJ ROUSSEAU OYONNAX (AIN) FR 01104

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-09-30