MAUDE Adverse Event Report: COSOPT PF DROPPER; DISPENSER, LIQUID MEDICATION

Device Problem Scratched Material (3020)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2021

Event Type  malfunction  

Event Description

Patient called to report a product issue with her individual, single use cosopt pf eye dropper.Patient stated that the eye dropper has sharp plastic corners on either side of the dropper, which makes it very hard to maneuver.She stated she loves the medication and has had no adverse event, but she feels the dropper is hard to use.

• Brand Name: COSOPT PF DROPPER
• Type of Device: DISPENSER, LIQUID MEDICATION
• MDR Report Key: 11453793
• MDR Text Key: 239240943
• Report Number: MW5099906
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR