MAUDE Adverse Event Report: OCUSOFT EYELID PADS; WEIGHTS, EYELID, EXTERNAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

User said the medication did not bring the patient the relief or healing she needed.

• Brand Name: OCUSOFT EYELID PADS
• Type of Device: WEIGHTS, EYELID, EXTERNAL
• MDR Report Key: 14312019
• MDR Text Key: 291237105
• Report Number: MW5109580
• Device Sequence Number: 1
• Product Code: MML
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2022
• Patient Sequence Number: 1
• Treatment: PREDNISOLONE 1%
• Patient Outcome(s): Other
• Patient Sex: Female