MalfunctionHJZ
PTOSE UP
Received Feb 23, 2023 · Event occurred Dec 6, 2022
Report MW5115156 · MDR key 16437248
Device
Generic name
Crutch, Ptosis
Manufacturer
Fci Ophthalmics / Fci SasCatalog number
S3.3001
Lot number
2201085
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Bacterial Infection
- Purulent Discharge
- Bacterial Infection
- Purulent Discharge
Narrative
Description of Event or Problem
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.