LIBERTY SPORT - LIBERTY SS2000 CHILDRENS EYEGLASSES TEMPLE PIN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-20 for LIBERTY SPORT - LIBERTY SS2000 CHILDRENS EYEGLASSES TEMPLE PIN manufactured by .

Event Text Entries

[5704310] My son is (b)(6) years old and has a condition called cerebral palsy. Because of his cerebral palsy, he falls easily. He also requires glasses. I would like to report liberty sport glasses with an protruding temple pin as a safety hazard. My son has fallen two times in the past month. On both occasions, he has fallen onto his right side, while wearing his glasses and the temple pin has penetrated his temple. Also on both occasions, he has required stitches. The first incidence occurred on (b)(6) and the second on (b)(6). The lacerations were in the same general area but not the exact spot. The first time it occurred, i thought that it was just a freak accident. But after occurring again, i thought that something must be done to make the glasses safer. It was a very traumatic event and i am concerned for the safety of other children. The company that manufactures the eyeglasses is liberty sport. Our particular style was called the liberty ss2000 and the hazard in the temple pin. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5042316
• MDR Report Key: 4730572
• Date Received: 2015-04-20
• Date of Report: 2015-04-09
• Date of Event: 2015-03-09
• Date Added to Maude: 2015-04-28
• 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: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIBERTY SPORT - LIBERTY SS2000 CHILDRENS EYEGLASSES TEMPLE PIN
• Generic Name: NONE
• Product Code: HQZ
• Date Received: 2015-04-20
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-04-20