MINER EYE PACK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-02-17 for MINER EYE PACK * manufactured by Medical Concepts Development, Inc..

Event Text Entries

[154921] Pt admitted for recess rectus bilateral eyes using surgical drape with adhesive. When the drapes were removed the child's eyelashes and eyebrows were removed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015709
• MDR Report Key: 210539
• Date Received: 1999-02-17
• Date of Report: 1999-02-09
• Date of Event: 1999-01-07
• Date Added to Maude: 1999-02-23
• 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
• 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: MINER EYE PACK
• Generic Name: CUSTOM PACK : DRAPE FOR EYE SURGERY
• Product Code: HMT
• Date Received: 1999-02-17
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 204302
• Manufacturer: MEDICAL CONCEPTS DEVELOPMENT, INC.
• Manufacturer Address: 2500 VENTURA DRIVE WOODBURY MN 551253927 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-02-17