RAY-BAN X-RAY W2219

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-28 for RAY-BAN X-RAY W2219 manufactured by Bausch & Lomb, Inc..

Event Text Entries

[41214] Consumer alleges an injury requiring medical treatment when he fell while riding his mountain bike.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1643383-1997-00003
• MDR Report Key: 72468
• Date Received: 1997-02-28
• Date of Report: 1997-02-24
• Date of Event: 1996-11-01
• Date Mfgr Received: 1996-12-04
• Date Added to Maude: 1997-03-05
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RAY-BAN
• Generic Name: SUNGLASS
• Product Code: HQY
• Date Received: 1997-02-28
• Returned To Mfg: 1996-12-04
• Model Number: X-RAY
• Catalog Number: W2219
• Lot Number: NA
• ID Number: *
• Device Availability: R
• Device Age: NA
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 72342
• Manufacturer: BAUSCH & LOMB, INC.
• Manufacturer Address: 5335 CASTROVILLE RD SAN ANTONIO TX 78227 US
• Baseline Brand Name: RAY-BAN SUNGLASSES
• Baseline Generic Name: SUNGLASSES
• Baseline Model No: X-RAY
• Baseline Catalog No: W2219
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-02-28