CRAYOLA KIDS CORY BLU 125 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-13 for CRAYOLA KIDS CORY BLU 125 * manufactured by Unk.

Event Text Entries

[19708613] Child tripped and fell on front steps of house while wearing glasses. Glasses broke at inner hinge between eye piece and ear piece creating jagged edges which lacerated the childs face from the outer corner of the eye to approx 1 inch down the cheek. Wound could not be sutured and md believes a scar will result.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1012778
• MDR Report Key: 143538
• Date Received: 1998-01-13
• Date of Report: 1998-01-13
• Date of Event: 1998-01-12
• Date Added to Maude: 1998-01-15
• Event Key: 0
• Report Source Code: Voluntary 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: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CRAYOLA KIDS
• Generic Name: CHILDREN'S EYEWEAR
• Product Code: HQZ
• Date Received: 1998-01-13
• Model Number: CORY BLU 125
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 140000
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-01-13