PREFORMED OCU-GUARD SUPPLE
Received Dec 19, 1998 · Event occurred Nov 20, 1998
Report 2183620-1998-00011 · MDR key 203636
Device
Generic name
Orbital Implant Wrap
Manufacturer
Bio-vascular, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Device Issue
Patient
31 YR
- Other (for use when an appropriate patient code cannot be identified)
- Surgical procedure, additional
Narrative
Description of Event or Problem
THE SURGEON REPORTED THAT ON 10/15/1998, HE PERFORMED AN ENUCLEATION PROCEDURE DUE TO THE PT HAVING NO USEFUL VISION IN THAT EYE AND THE CONDITION OF THE EYE BEING PAINFUL TO THE PT. ON 11/20/1998, THE PT PRESENTED WITH EXPOSUE OF THE HYDROXYAPETITE ORBITAL IMPLANT, WHICH THE PREFORMED OCU-GUARD SUPPLE IS USED TO COVER. ON 12/16/1998, THE SURGEON PUT A DERMIS GRAFT OVER THE HYDROXYAPETITE ORBITAL IMPLANT. THE PREFORMED OCU-GUARD SUPPLE ORBITAL WRAP WAS NOT EXPLANTED. THE SURGEON DOES NOT ATTRIBUTE THE INCIDENT TO THE USE OF THE PREFORMED OCU-GUARD SUPPLE PRODUCT. THE CONDITION OF THE PT IS CURRENTLY STABLE.