MAUDE Adverse Event Report: FCI SAS FCI RITLENG HOOK; HOOK, OPHTHALMIC

Catalog Number S1.1480

Patient Problem Insufficient Information (4580)

Event Date 01/29/2024

Event Type  Injury  

Event Description

Tip of ritleng hook broke off during procedure.Patient had to have follow up x-rays.

• Brand Name: FCI RITLENG HOOK
• Type of Device: HOOK, OPHTHALMIC
• Manufacturer (Section D): FCI SAS
• MDR Report Key: 18704442
• MDR Text Key: 335461763
• Report Number: MW5151582
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S1.1480
• 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): Required Intervention
• Patient Age: 24 MO
• Patient Sex: Male