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

Catalog Number S3.3001

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

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812)

Event Date 12/06/2022

Event Type  malfunction  

Event Description

Surgery #1 was performed on (b)(6) 2022 and the implant was removed on (b)(6) 2023 secondary to an infection of the lt eyelid with purulent drainage.The culture grew 1+ staphylococcus aureus within 24 hours of the specimen being sent to the laboratory.

• Brand Name: PTOSE UP
• Type of Device: CRUTCH, PTOSIS
• Manufacturer (Section D): FCI OPHTHALMICS / FCI SAS
• MDR Report Key: 16437248
• MDR Text Key: 310331223
• Report Number: MW5115156
• 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: S3.3001
• Device Lot Number: 2201085
• 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