BEIERSDORF - JOBST CHILD EYE OCCLUSOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-01-18 for BEIERSDORF - JOBST CHILD EYE OCCLUSOR * manufactured by Beiersdorf - Jobst, Inc..

Event Text Entries

[20240999] Male infant has congenital cataract, and needs eye occlusor daily. Found beirsdorf occlusor to be satisfactory until mfr changed adhesive. Now pt unable to use because of harsh adhesive and skin sensitivity to product.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015470
• MDR Report Key: 206761
• Date Received: 1999-01-18
• Date of Report: 1999-01-18
• Date of Event: 1999-01-10
• Date Added to Maude: 1999-01-21
• 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: BEIERSDORF - JOBST
• Generic Name: EYE PATCH
• Product Code: HOY
• Date Received: 1999-01-18
• Model Number: CHILD EYE OCCLUSOR
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 200692
• Manufacturer: BEIERSDORF - JOBST, INC.
• Manufacturer Address: 5825 CARNEGIE BLVD CHARLOTTE NC 282094633 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Congenital Not Applicablenomaly; 2. Required No Informationntervention	1999-01-18