MAUDE Adverse Event Report: FCI OPHTHALMICS / FCI SAS PTOSE UP; CRUTCH, PTOSIS

Catalog Number SC 3021

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

Patient Problem Eye Infections (4466)

Event Date 12/16/2022

Event Type  malfunction  

Event Description

Surgery #2 was performed on (b)(6) 2022 and the implant was removed on (b)(6) 2022 secondary to an infected frontalis sling of the left eye (may be the rt eye as the two operative reports list rt eye on the original surgery and lt on the implant removal).Purulent drainage was also noted.The culture grew 1+ staphylococcus aureus within 24 hours of the specimen being sent to the lab.

• Brand Name: PTOSE UP
• Type of Device: CRUTCH, PTOSIS
• Manufacturer (Section D): FCI OPHTHALMICS / FCI SAS
• MDR Report Key: 16437241
• MDR Text Key: 310330821
• Report Number: MW5115155
• Device Sequence Number: 1
• Product Code: HJZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SC 3021
• Device Lot Number: 2201084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other